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Policy PointsCurrent medical device regulatory frameworks date back half a century and are ill suited for the next generation of medical devices that involve a significant software component.Existing Food and Drug Administration efforts are insufficient because of a lack of statutory authority, whereas international examples offer lessons for improving and harmonizing domestic medical device regulatory policy.A voluntary alternative pathway built upon two‐stage review with individual component review followed by holistic review for integrated devices would provide regulators with new tools to address a changing medical device marketplace [ABSTRACT FROM AUTHOR]

Purpose: The incoming Canadian cohort of medical students is comprised mainly of individuals from Generation Z (Gen Z; born between 1997 and 2012), with greater than 50% of applicants identifying as female. A gap remains in our understanding of Gen Z women learners in their challenges in navigating medical education, their expectations for their medical careers and the influences that have impacted their worldview. This study explored the needs, values, and experiences of Gen Z women medical students and the impact of these factors on mentorship expectations among this population that will soon be entering the workforce. Methods: Upon receiving ethics approval from the University of Toronto Research Ethics Board, semi‐structured interviews were conducted (February–May 2021) with 15 Gen Z women students from 14 English‐speaking Canadian medical schools who had given written consent to participate. An iterative constant comparative team approach was utilised in which the interview guide and sampling were adjusted as the data evolved. Transcripts were line by line coded into categories, then grouped into themes using descriptive analysis. Results: These socially aware learners described how society had afforded them greater opportunities for expression, which gave them a sense of feeling advantaged over older generations. However, participants paradoxically expressed feelings of powerlessness and commented on tensions they experienced when interacting with older generation physician mentors, especially during conversations on social justice issues. They also highlighted instances of biased mentorship specific to their gender. Participants emphasised a desire for inclusive mentorship that considered the mentee's identity and intersectionality. Conclusions: The growing number of women learners in Canadian medical schools necessitates a re‐evaluation of mentorship delivery. Mentors must adapt by integrating Gen Z ideals to overcome mentorship challenges. [ABSTRACT FROM AUTHOR]

The recent clearance by the United States Food and Drug Administration of Tidepool Loop sets an important precedent within the medical device landscape. For the first time, an automated insulin delivery mobile application—based on an algorithm initially designed and developed by users —has been recognised as safe and effective by a regulatory body. The aim of this paper is twofold: firstly, we map out the regulatory pathways and processes that were navigated by Tidepool, the non‐profit behind Tidepool Loop, in order to make this landmark moment possible. Secondly, we set out potential approvals processes in the European Union and United Kingdom with a view to examining the challenges to obtaining regulatory clearance for Tidepool Loop in these jurisdictions. In so doing, we highlight the significant differences, not only between the United States and European systems but also between the European Union and Great Britain systems. We conclude by arguing that the complexity encountered when seeking to introduce an innovative solution in different regulatory systems has the potential to act as a disincentive to open source developers from seeking regulatory approvals for such technologies in the future. [ABSTRACT FROM AUTHOR]

INTRODUCTION The majority of decisions on electronic nicotine delivery system (ENDS) premarket tobacco product applications (PMTAs) were made from October 2020 to February 2023; 99% (>25 million) had determinations by March 2023 and just twenty-three received marketing granted orders. We examined the unique devices and liquids used among US adults frequently using ENDS before, during, and after a majority of PMTA decisions were made. METHODS Data are from waves 1-5 (W1: May-Oct 2020, n=1179; W5: Feb-Apr 2023, n=1290) of a longitudinal survey of US adults (≥21 years) using ENDS ≥5 days/week. User-submitted photos of participants' most used devices and liquids were coded. Descriptive analyses and Wilcoxon signed-rank tests were used to understand the number and types of unique devices and liquids used in W1-W5, and the top brands in each wave. RESULTS From W1-W5, the number of unique ENDS device models and liquid products used by participants increased from 279 to 357 (p<0.001) and 546 to 695 (p<0.001), respectively. More unique devices in W5 versus W1 were disposable (W1: 16.5%; W5: 36.1%); fewer were disposable pod (W1: 6.5%; W5: 3.1%) or tank (W1: 53.8%; W5: 30.8%) devices. Liquids were primarily sweetflavored (W1: 81.1%; W5: 82.0%). The median liquid nicotine concentration increased from 12 to 50 mg/mL. In W5, few participants used FDA-approved devices (n=17; 1.3%) or liquids (n=6; 0.5%), and Elf Bar was the most commonly used device and liquid brand. Results for all waves are reported. CONCLUSIONS Despite PMTA decisions, an increase in the number of unique device models and liquid products used among adults who frequently use ENDS was observed from 2020 to 2023. Few participants in 2023 were using FDA-approved devices or liquids. Further research and monitoring are needed to inform how FDA prioritizes enforcement actions and what types of enforcement actions are effective. [ABSTRACT FROM AUTHOR]

Attention-deficit/hyperactivity disorder (ADHD) is a childhood-onset disorder characterized by pharmacological and non-pharmacological interventions. Despite the available treatment options and prevention measures, conventional treatments have several limitations. Digital therapeutics (DTx) like EndeavorRx® is an emerging alternative to overcome these limitations. EndeavorRx® is the first FDA-approved, game-based DTx approved for the treatment of pediatric ADHD. We investigated the effects of game-based DTx in randomised controlled trials (RCTs) on children and adolescents with ADHD. In this systematic review and meta-analysis, we searched PubMed, Embase, and PsycINFO databases up to January 2022. The protocol was registered (CRD42022299866). The assessor was defined as parents and teachers. The primary outcome was differences in inattention reported by the assessor, and the secondary outcome was differences in hyperactivity and hyperactivity/impulsivity reported by the assessor and the relative comparisons between game-based DTx, medicine, and control with indirect meta-analysis. Game-based DTx improved inattention more than the control upon assessment by assessors (standard mean difference (SMD) 0.28, 95% confidence interval (CI) 0.14–0.41; SMD 0.21, 95% CI 0.03–0.39, respectively), while medication improved inattention more than game-based DTx (SMD − 0·62, 95% CI − 1·04 to − 0·20) upon assessment by the teacher. Game-based DTx improved hyperactivity/impulsivity than the control upon assessment by assessors (SMD 0.28, 95% CI 0.03–0.53; SMD 0.30, 95% CI 0.05–0.55, respectively), and medication improved hyperactivity/impulsivity significantly than game-based DTx upon assessment by the teacher. Hyperactivity has not been reported extensively. As a result, game-based DTx had a more significant effect than the control, however medication was more effective. [ABSTRACT FROM AUTHOR]

BACKGROUND: Device classification and preclinical data requirements for animal-derived wound care products were recently reviewed by the FDA. Given the possible performance differences for these products, we evaluated the FDA data requirements as well as the published literature for all animal-derived wound care products ever cleared through the FDA. STUDY DESIGN: The publicly available online database was queried for all animal-derived wound products; premarket data requirements for each product were recorded. A PubMed search was conducted to determine the number of published clinical studies for each product, and manufacturer websites were accessed to obtain the price for each product. RESULTS: A total of 132 animal-derived wound products have been cleared by the FDA since the Center for Devices and Radiological Health was established in 1976. Of these, 114 had a publicly available clearance statement online. Preclinical biocompatibility testing was performed in 85 products (74.6%) and referenced in 10 (8.8%). Preclinical animal wound healing testing took place in 17 (14.9%). Only 9 products (7.9%) had clinical safety testing, and no products had clinical effectiveness data. We found no published peer-reviewed clinical data for 97 products (73%). Cost was infrequently available but ranged from $4.79 to $2,178 per unit. CONCLUSIONS: Although the current pathway is appropriate for efficiently clearing new wound care products, clinical effectiveness is not included in the regulatory review process. Wound care products are primarily evaluated by the FDA for safety and biocompatibility. Thus, any claims of clinical effectiveness require independent validation, which is often lacking. [ABSTRACT FROM AUTHOR]

The US government supports drug innovation. It is therefore crucial that it distinguish between high-value and low-value innovation in purchasing expensive prescription drugs and medical devices and ensure the continued discovery of transformative drugs and that patient and taxpayer funds are not wasted. [ABSTRACT FROM AUTHOR]

Both respirators and surgical masks (SM) are used as source control devices. During the COVID-19 pandemic, there was much interest in understanding the extent of particle total outward leakage (TOL) from these devices. The objective of this study was to quantify the TOL for five categories of devices: SMs, National Institute for Occupational Safety and Health (NIOSH) Approved N95 filtering facepiece respirators (FFRs) without exhalation valves, NIOSH Approved N95 FFRs with exhalation valves (N95 FFRV), NIOSH Approved elastomeric half-mask respirators (EHMRs) with exhalation valves, and NIOSH Approved EHMRs with an SM covering the exhalation valve (EHMRSM). A benchtop test system was designed to test two models of each device category. Each device was mounted on a headform at three faceseal levels (0% faceseal, 50% faceseal, and 100% faceseal). At each faceseal level, the TOL was assessed at three flow rates of minute ventilations of 17, 28, and 39 L/min. The experimental design was a split-split-plot configuration. Device type, faceseal level, flow rate, and the interaction of device type and faceseal level were found to have a significant effect ( p - value < 0.05) on the TOL. This study found that the N95 FFRs without exhalation valves had the lowest mean TOL. The SMs had about three times higher TOL than the N95 FFRs without exhalation valves. The TOL of the N95 FFRV was comparable to that of the SM at 0% and 50% faceseal on average overall conditions, but the N95 FFRV had a significantly higher TOL than the SM at a 100% faceseal. The EHMRs had the highest TOL because of the exhalation valve. Using an SM to cover the exhalation valve did not improve the EHMRs' efficiency in mitigating the TOL. Caution should be exercised when using N95 FFRVs as a source control measure against respiratory activities with heavy work rates, such as performing CPR. Results of this study showed that reduced faceseal leakage for N95 FFRs and SMs improves source control. [ABSTRACT FROM AUTHOR]

The care of patients with heart rhythm disorders is often dependent on technologies developed to address their unique clinical needs. Although much innovation occurs in the United States, recent decades have seen a significant proportion of early clinical studies performed outside the United States, driven largely by costly and time‐inefficient processes seemingly inherent to the United States research ecosystem. As a result, the goals of early patient access to novel devices to address unmet needs and efficient technology development in the United States remain incompletely realized. This review will introduce key aspects of this discussion, organized by the Medical Device Innovation Consortium, in an effort to broaden awareness and encourage engagement by stakeholders in an effort to address central issues and therefore further a growing effort to shift Early Feasibility Studies to the United States for the benefit of all involved. [ABSTRACT FROM AUTHOR]

Purpose: This article presents the evolution of the subject of vascular anatomy and discusses the associated clinical applicability. Methods: Clinically-driven surgical examples met in our everyday practice were used to depict characteristic anatomical paradoxes raised by the inconsistencies between classical anatomical perception, current imaging modalities and modern surgical techniques. Results: Consequent anatomy-driven modifications of medical devices comprise a characteristic example of the vivid, modern and meaningful role that anatomy can have on clinical decision-making and improvement of technical and clinical success. Clinical experience provides a feedback that shifts the focus of anatomic research towards new fields of interest, such as the role of arterial collateral networks as therapeutic targets. The clinical feedback brings into light queries and issues where traditional anatomical answers may be vague and inadequate to apply, thereby necessitating further research, refinement and reevaluation. Conclusion: While the traditional teaching of vascular anatomy is based on information and illustrations derived from dissection and prosection courses, the development of modern imaging technologies applied in large numbers of living patients and application of minimally invasive techniques challenge our understanding of what should be perceived as fixed and permanent. Moreover, the recently introduced evidence-based philosophy in anatomy elaborate more robust data which not only update, validate and enrich the existing knowledge of anatomical variations but also enable subgroup analyses with respect to race, age and sex, identifying specific anatomic features associated with a significant impact on patient treatment. [ABSTRACT FROM AUTHOR]

Every year, the Food and Drug Administration (FDA) clears approximately 3,000 medical devices for marketing via the 510(k) pathway. These constitute 99% of all devices approved for human use and includes the premarket review of many devices incorporating newer technology such as artificial intelligence (AI), machine learning (ML), and other software. As the complexity of these novel technologies and the number of applications is expected to increase in the coming years, statutory changes such as the 2016 21st Century Cures Act, regulations, and guidance documents have increased both the volume and complexity of device review. Thus, the ability to streamline the review of less complex, low-to-moderate risk devices through the 510(k) pathway will maximize the FDA's capability to address other important, future-oriented regulatory questions. For over twenty five years, third party review organizations have served a defined function to assist with the review of 510(k) applications for a set of enumerated device classes. This paper reviews the history of FDA device regulation, the evolution of the 510(k) review pathway, and the recent history of the 510(k) third party review program. Finally, the paper addresses policy concerns from all stakeholders – including the FDA – along with policy suggestions to improve the third party review program and FDA device regulation writ large. [ABSTRACT FROM AUTHOR]

Purpose: Voice dosimeters gather voice production data in the daily lives of individuals with voice disorders. Additionally, voice dosimeters aid in understanding the pathophysiology of voice disorders. Previously, several voice dosimeters were commercially available. However, these devices have been discontinued and are not available to clinicians and researchers alike. In this tutorial, instructions for a low-cost, easy-to-assemble voice dosimeter are provided. This do-it-yourself (DIY) voice dosimeter is further validated based on performance results. Method: Ten vocally healthy participants wore the DIY voice dosimeter. They produced a sustained /a/ vowel and read a text with three different vocal efforts. These tasks were recorded by the DIY voice dosimeter and a reference microphone simultaneously. The expanded uncertainty of the mean error in the estimation of four voice acoustic parameters as measured by the DIY dosimeter was performed by comparing the signals acquired through the reference microphone and the dosimeter. Results: For measures of sound pressure level, the DIY voice dosimeter had a mean error of −0.68 dB with an uncertainty of 0.56 dB. For fundamental frequency, the mean error was 1.56 Hz for female participants and 1.11 Hz for male participants, with an uncertainty of 0.62 Hz and 0.34 Hz for female and male participants, respectively. Cepstral peak prominence smoothed and L1 minus L2 had mean errors (uncertainty) of −0.06 dB (0.27 dB) and 2.20 dB (0.72 dB). Conclusion: The mean error and uncertainties for the DIY voice dosimeter are comparable to those for the most accurate voice dosimeters that were previously on the market. [ABSTRACT FROM AUTHOR]

BACKGROUND: Cumulative hydrochlorothiazide (HCTZ) use is linked to the development of nonmelanoma skin cancers. In August 2020, the U.S. FDA approved changes to the HCTZ drug label to indicate this. OBJECTIVE: To uncover what proportion of dermatologists are aware of this association and how often screening and counseling are performed. MATERIALS AND METHODS: An observational, cross-sectional survey assessing risk awareness and counseling frequency and barriers was distributed among academic dermatologists. Chi-square tests compared resident and attending respondent data. RESULTS: A total of 83 respondents completed the questionnaire; most endorsed awareness of the association between HCTZ use and nonmelanoma skin cancer development before the survey, yet only 28.9% of respondents were aware of changes to the HCTZ drug label. A greater proportion of attendings than residents were aware of the association and drug label changes. The most reported barrier to counseling was the lack of specific screening guidelines for patients taking HCTZ. CONCLUSION: Concerted efforts should be made in residency training and continuing medical education to ensure dermatologists are aware of this well-established link. Specialty-specific efforts should be made to implement clear guidelines on best screening practices and optimized counseling strategies for patients taking HCTZ. [ABSTRACT FROM AUTHOR]

This article aims to summarize the development and challenges of real-world data (RWD) and real-world evidence (RWE) in China and introduce a unique opportunity for medical devices to gain accelerated regulatory approval in China by utilizing RWE generated in a free trade pilot zone "Boao Lecheng" in Hainan Province. In 2020, the National Medical Products Administration (NMPA) issued a draft guideline on the "Use of real-world data to support clinical evaluation for medical devices", suggesting that RWE derived from RWD could support clinical evaluation throughout the life cycle of a medical device. Meanwhile, the Chinese government has allowed qualified RWD collected in Boao Lecheng to support registration application of innovative medical devices and drugs in China. These medical devices and drugs should have been approved abroad, but not in China yet, and met urgent and unmet medical needs in China. The article also presents the successful story of an innovative Glaucoma drainage tube as the first medical device approved in China using RWE generated in Boao Lecheng in 2020. Although we are witnessing an increased interest in RWE, a few challenges remain, e.g., limited data accessibility and data sharing, concerns on data quality, etc. Collaborations among relevant stakeholders in the RWE research are vital to address the challenges. [ABSTRACT FROM AUTHOR]

The assigned protection factor (APF) for quarter-facepiece respirators is currently 5, based on fit test data from the 1970s with models no longer commercially available. The goal of this project was to evaluate the respirator fit capability of a NIOSH-approved N95 quarter-facepiece elastomeric respirator with a gel-based facial seal design (Envo Mask by Sleepnet Corporation). Human subjects were recruited from healthcare and the general population to satisfy a 25-member NIOSH bivariate panel. Subjects were fit tested with a fast fit protocol using a TSI Portacount Model 8038 in the N95 mode. Second-by-second measures of fit were then collected while subjects performed a 30-min series of simulated healthcare activities. Subjects completed a short comfort questionnaire. The median (5th, 95th percentile) fit factor was 188 (48, 201). Simulated workplace protection factors (SWPFs) had a median (5th, 95th percentile) of 181 (94, 199) (data truncated at 200) and 570 (153, 1508) (non-truncated data). Subjects ranked inhalation and exhalation as "easy" with average scores of 5.0/6.0 and 5.2/6.0, respectively. The facepiece was ranked between slightly comfortable and comfortable (4.8/6.0) and the harness as comfortable (5.0/6.0). Most users agreed (5.2/6.0) that the mask was stable on their faces. The 5th percentile SWPF of 95 supports an APF of at least 10 for this quarter-facepiece elastomeric respirator, similar to the APF for half-facepiece respirators. This study supports increasing the APF for quarter-facepiece respirators, a class that has been largely ignored by manufacturers for the past 40 years. A lightweight, low profile, reusable quarter-facepiece respirator is an effective option for healthcare and other worker protection during a pandemic and similar situations. [ABSTRACT FROM AUTHOR]

Background: Commercially available products used in knee cartilage reconstructive and restorative surgical practices fall under unique US Food and Drug Administration (FDA) regulatory pathways that determine the level of evidence required to market each product. Purpose: To evaluate the levels of evidence in the literature supporting commercially available cartilage repair procedures stratified by FDA regulatory pathway (section 351 vs section 361 of "Human Cells, Tissues, and Cellular and Tissue-Based Products" [HCT/P] in the Code of Federal Regulation) with the hypothesis that products requiring approval under a stringent regulatory pathway (351 HCT/P) have higher levels of evidence in the literature supporting use and that products with a less stringent regulatory pathway (361 HCT/P) have a higher number of products available for use in the United States. Study Design: Systematic review; Level of evidence, 4. Methods: A search of the PubMed database was performed to identify all peer-reviewed articles pertaining to either allograft or autologous cartilage repair technologies. Predefined inclusion and exclusion criteria were used to find clinical, preclinical, and laboratory studies while excluding duplicates, systematic reviews, and products not available in the United States. Articles were categorized by regulatory pathway (351 and 361 HCT/P), and variables including publication year, type of publication, level of evidence, and number of publications were analyzed. Results: After application of predefined criteria, 470 of 1924 articles were included in this study. The 351 HCT/P group was composed entirely of autologous chondrocyte implantation (ACI) technology; 94% of the 361 HCT/P group was composed of osteochondral allografts (OCA). The articles regarding 351 HCT/P were more likely to be clinical in nature than the articles on 361 HCT/P (80% vs 48%, respectively; P =.0001) and entailed significantly more level 1 studies (25 vs 0, respectively; P <.0001). Twice as many articles in the 351 HCT/P group were published in the American Journal of Sports Medicine compared with the 361 HCT/P group (71 vs 38, respectively; P =.18). Conclusion: Both ACI and OCA have robust evidence supporting their use, whereas the remaining regulated products have little or no supporting evidence. Technologies regulated by 351 HCT/P were more likely to be level 1 clinical studies and published in the highest impact journal. The 361 HCT/P pathway regulated many more products, with fewer articles supporting their use. [ABSTRACT FROM AUTHOR]

Simple Summary: There is a great need to understand the cellular and molecular characteristics of cancer when access to the tumor is limited. Circulating tumor cells (CTCs) captured from the blood of cancer patients may serve as a surrogate source of tumor material. However, the only FDA-cleared CTC assay has been limited to counting CTC in blood and and lack further characterization of the CTCs. In this study, we tested the Parsortix® PC1 System that captures and harvests a wide range of CTCs from peripheral blood that are amenable for further evaluation. The device was assessed in a large, multicenter clinical trial including patients with metastatic breast cancer and healthy volunteers, with enriched CTC evaluated by 4 downstream techniques commonly available in clinical laboratories. The data generated from this study was used to support FDA clearance for the Parsortix System. Circulating tumor cells (CTCs) captured from the blood of cancer patients may serve as a surrogate source of tumor material that can be obtained via a venipuncture (also known as a liquid biopsy) and used to better understand tumor characteristics. However, the only FDA-cleared CTC assay has been limited to the enumeration of surface marker–defined cells and not further characterization of the CTCs. In this study, we tested the ability of a semi-automated device capable of capturing and harvesting CTCs from peripheral blood based on cell size and deformability, agnostic of cell-surface markers (the Parsortix® PC1 System), to yield CTCs for evaluation by downstream techniques commonly available in clinical laboratories. The data generated from this study were used to support a De Novo request (DEN200062) for the classification of this device, which the FDA recently granted. As part of a multicenter clinical trial, peripheral blood samples from 216 patients with metastatic breast cancer (MBC) and 205 healthy volunteers were subjected to CTC enrichment. A board-certified pathologist enumerated the CTCs from each participant by cytologic evaluation of Wright-Giemsa-stained slides. As proof of principle, cells harvested from a concurrent parallel sample provided by each participant were evaluated using one of three additional evaluation techniques: molecular profiling by qRT-PCR, RNA sequencing, or cytogenetic analysis of HER2 amplification by FISH. The study demonstrated that the Parsortix® PC1 System can effectively capture and harvest CTCs from the peripheral blood of MBC patients and that the harvested cells can be evaluated using orthogonal methodologies such as gene expression and/or Fluorescence In Situ Hybridization (FISH). [ABSTRACT FROM AUTHOR]

In sum, warning labeling for alternative nicotine/tobacco products needs to both identify the product as a nicotine product and warn users that nicotine is an addictive chemical. Second, nicotine content should be clearly printed on products that contain nicotine, including disposable e-cigarettes, e-cigarette cartridges, and the innermost packaging of oral nicotine products (eg, blister packs of gum). Labeling of emerging commercial nicotine products - including electronic cigarettes (e-cigarettes) and new non-tobacco oral nicotine products - is insufficient for the protection of public health. [Extracted from the article]

An editorial is presented on the safety and efficacy assessments of (Hybrid) Closed Loop systems, emphasizing the need to incorporate minimum exercise data in regulatory approval. Topics include discrepancies in regulatory standards for continuous glucose monitoring systems, challenges in continuous glucose monitoring (CGM) accuracy during physical activity, and the importance of integrating exercise data for the development of fully closed-loop systems for individuals with type 1 diabetes.

The article discusses the hemostatic mechanisms of intrauterine hemostatic devices, specifically focusing on the Jada System. It points out that while conventional intrauterine balloons and the Jada System operate on different principles, the commonality lies in the intrauterine insertion of the device, which induces uterine contractions contributing to hemostasis.

The mission of Food and Drug Administration (FDA)'s Center for Devices and Radiological Health is to protect and promote public health. It assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products by providing meaningful and timely information about the products we regulate and the decisions we make. On September 17, 2021, an FDA workshop was held to provide information to stakeholders, including members of the spine community, device manufacturers, regulatory affairs professionals, clinicians, patients, and the general public regarding FDA regulations, guidance and regulatory pathways related to spinal device clinical review. It was not intended to communicate any new policies, processes, or interpretations regarding medical device marketing authorizations. This workshop consisted of individual presentations, group discussions, question and answer sessions, and audience surveys. Information-sharing included discussions related to patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes. Discussions involving external subject matter experts covered topics related to spinal device clinical studies including definition of a target population, enrollment criteria, strategies for inclusion of under-represented patient groups, reporting of adverse event and secondary surgical procedures, clinical study endpoints, and clinical outcome assessments. A meeting transcript and webcast workshop link are currently posted on the FDA website. Important related issues and challenges were discussed, and an exciting range of new ideas and concepts were shared which hold promise to advance regulatory science, patient care and future innovation related to spinal devices. [ABSTRACT FROM AUTHOR]

Recently receiving Food and Drug Administration approval, the Amplatzer Amulet™ left atrial appendage occluder device (Abbott Medical Inc.) provides a dual seal mechanism alternative to the commercially available Watchman FLX or Watchman 2.5 device for embolic stroke prevention in patients with nonvalvular atrial fibrillation. This step‐by‐step review will cover patient selection, preprocedure imaging assessment, device sizing, device preparation, implant target position assessment, implant technique and troubleshooting, and immediate postimplant follow‐up. [ABSTRACT FROM AUTHOR]

Objective: The MitraClip from Abbott is FDA approved intracardiac implantable device for transcatheter edge-to-edge repair (TEER). Despite a few previously published studies, there is limited safety data for its use in clinical practice, hence, we designed this study using data obtained from a safety nationwide database to demonstrate the safety profile of MitraClip.Methods: The first two of the five authors independently queried all reported adverse events from the United State Food and Drug Administration [FDA] Manufacturer and User Facility Device Experience [MAUDE] registry from January 2014 to December 2020. The primary end point was trend in reported fatal events obtained from this database. The secondary end points included the causes of reported nonfatal reports from the MAUDE registry. The trend of reported fatal events was assessed using the Cochran Armitage trend test over the period of the study.Results: During the study period, subjects included 3370 patients whose MitraClip-associated adverse events were reported and captured by MAUDE registry. Of these, 211 were fatal and 3159 nonfatal events. Fatal event reports resulted deaths and reported nonfatal events were from injuries and device system malfunction. This study demonstrated an initial upward trend from 2014 to 2015 then a subsequent statistically significant downward trend in reported fatal events from 2015 to 2020 (Cochran-Armitage test P = 0.039). The peak proportion of reported fatal events occurred in 2015, (n = 44; representing 1.25% of reported adverse events) and lowest proportion of reported fatal events took place in 2020 (n = 19; representing 0.56% of reported adverse events). The most reported nonfatal events were from malfunctioning of MitraClip system (n = 1170; representing 37% of reported nonfatal events), new unremarkable repolarization abnormalities on periprocedural EKG (n = 864; representing 27% of reported nonfatal events), leaflet rupture (n = 651; representing 21% of reported nonfatal events), and cardiogenic shock (n = 170; representing 5% of reported nonfatal events).Conclusions: This analysis of the MAUDE Registry indicated, especially within the confines of this study's limitations and poor data quality of information, an apparent downward trend of reported fatal events over the study period. Even though conclusive attributions cannot be made regarding this important finding, perhaps, this points to early evidence of a potential institutional or operator learning curve with this device. However, in view of the inferior quality of the data accrued from the MAUDE Registry, more high-precision studies are needed to better understand these changes, as the utility of MitraClip, becomes more established in clinical practice. [ABSTRACT FROM AUTHOR]

Few medical devices are designed and marketed specifically for children. Instead, adult devices are often repurposed and used off-label in pediatrics. The innovation gap between pediatric and adult devices is complex and multifactorial. This review aims to summarize the medical device landscape, describe barriers to pediatric device development, and provide an update on current strategies to help overcome these limitations. Medical devices are regulated by the Food and Drug Administration. They are registered, cleared, or approved on the basis of a 3-tier risk classification system and a differentiated set of regulatory pathways. This includes some for products that receive special designations on the basis of specific aspects that warrant more rapid review and approval. Pediatric devices number only one-quarter of those developed for adults for multiple reasons. Clinically, innovators must adjust their products to address the smaller sizes, growth, and longer duration of use in children. Smaller sample sizes and population heterogeneity also challenge the ability to obtain sufficient safety data for regulatory submissions. Financial concerns stem from lower pediatric reimbursement rates coupled with a lack of nationally standardized coverage. There are a number of promising initiatives, including the Pediatric Device Consortia Program, Early Feasibility Studies, and the new System of Hospitals for Innovation in Pediatrics -- Medical Devices. However, the gap will likely not be narrowed without broad cooperation across stakeholders from industry, academia, patient advocacy groups, health care providers, investors, payors, regulators, and Congress. [ABSTRACT FROM AUTHOR]

Background: Medical faculty and residents have a key role in the reporting of adverse events associated with medical devices. However, at present, there are no published data regarding their knowledge, attitude, and practice about materiovigilance in India. Materials and Methods: This was a cross-sectional questionnaire-based survey done among medical faculty and residents of a tertiary care institution of national importance. The questionnaire consists of 15 questions pertaining to knowledge, attitude, and practice of materiovigilance. Results: The questionnaire was administered to 138 medical faculty and residents, out of which 105 responded constituting a 76% response rate. The mean knowledge score of medical faculty and residents was 2.09 ± 1.06 and 2.07 ± 1.02, respectively, and the difference between the two groups was not statistically significant (P = 0.9). The majority of the participants (92.63%) believed that medical device can cause adverse events; however, very few of them (20.13%) have reported it during their practice. Conclusion: Requisite knowledge and appropriate attitude are essential for developing healthy practice toward reporting of adverse events associated with medical devices. Our study revealed that the knowledge gap exists among medical professionals about the reporting of adverse events and the materiovigilance program. A continuous effort is required to make them aware of the materiovigilance by conducting various training programs such as continuous medical education and workshops by the coordinators of the medical device adverse events monitoring center. [ABSTRACT FROM AUTHOR]

The article presents the discussion on news related to diabetes. Topics include very-low-energy diets and formula meal replacements being likely the most effective approaches for weight reduction in diabetes; and starting glucose lowering prescription drugs being the best group for initiating discussions around remission and weight management.

Dialysis treatment for chronic kidney disease was first developed by Dr. Willem Kolff in 1943, and its availability began to grow in 1962 after which it has become a mainstay treatment for patients with chronic kidney disease. It is estimated that, in 2021, 15% of adults in the United States (∼37 million people) have chronic kidney disease, of which 661,000 individuals have renal failure, and 468,000 individuals require dialysis. There have been several advancements in dialysis treatment since its advent, most notably the creation of arteriovenous fistulas (AVFs) for venous access in 1966. In recent years, the U.S. Food and Drug Administration approved two new devices for AVF creation using a percutaneous approach. These are the WavelinQ (Becton Dickinson, New Jersey) and the Ellipsys (Avenu Medical, California) endovascular AVF (endoAVF) devices that use radiofrequency and thermal technologies, respectively, to create the AVF. Since the introduction of these technologies, several studies have shown that they are safe and effective, with favorable durability and low rate of serious adverse events. In this article, we will discuss these two devices and the techniques used for percutaneous creation of dialysis AVF as an alternative to traditional open surgical techniques. [ABSTRACT FROM AUTHOR]

Objectives: Endovenous Radio-frequency Ablation (RFA) has become a common treatment for chronic venous insufficiency. The Medtronic® Closurefast catheter was previously the only RFA catheter approved for use in this procedure. In 2018 VenClose® Company's new device was approved. As there has been little literature on this new device, we examined our results with this new alternative. Methods: Patients with symptomatic venous insufficiency had their lower extremities mapped via ultrasound. If superficial reflux (>.5 s) was found the patients were recommended a 6-week conservative course of compression stockings, elevation, and NSAIDs. If conservative treatment failed, the patient was scheduled for an RFA. The procedure was done at the outpatient clinic, instructions were given to return for follow-up in 3-5 days, and every 3 months thereafter for the first year. 1032 procedures were performed over 14 months. Results: We had 503 patients, 69% female, mean age 54 ± 12. Under the CEAP system, clinical manifestation portion, the majority of our limbs were class C3 and class C4. The majority of veins closed were GSV above knee and SSV. Follow-up duration ranged from 1 to 276 days (Mean (M) = 10 SD: 20 days). Our success rate was 99.32% at initial follow-up. We observed EHITs in 12 cases (1.16%), 8 of which were class I, 2 of which were class II, and 2 of which were class III. We noted SVTs of proximal varicose veins in 40 cases (3.88%) and SVT of distal GSV in 4 cases (.38%). There were 4 (.38%) cases of DVT, 3 in calf muscular veins (.29%), and one in a perforator vein (.09%). We observed two cases of puncture abscess (.193%), 8 cases of infection at the puncture site (.77%), with 8 infections occurring at locations other than the puncture site and not as a result of the procedure. Conclusion: These preliminary results indicate that this new machine and catheter are promising with low rates of EHIT, recanalizations, and other complications. It is important to research this catheter and further studies should continue to follow up to examine recanalization rates over a more long-term follow-up. [ABSTRACT FROM AUTHOR]

Objectives: To enhance the generalizability of the evidence it reviews, the US Food and Drug Administration (FDA) has encouraged manufacturers to expand the submission of real-world evidence (RWE). The extent to which this evidence, which is generated outside of research settings, can support decision making remains unclear. We described the current use of RWE for medical devices, assessed manufacturers' challenges in generating and using it for regulatory and coverage decisions, and identified opportunities to expand its use.Methods: We conducted 27 solo and group interviews with FDA officials and representatives of device manufacturers, payers, and health technology assessment organizations. All interviews used a semistructured protocol and were transcribed to allow thematic analysis.Results: Accessing and linking real-world data sources, identifying unique devices, capturing longitudinal data, limited staff expertise, and uncertain return on investment have hampered efforts to use real-world data. Many companies in our sample were conducting research using real-world data, but none had submitted RWE as the primary evidence supporting a premarket approval. FDA guidance was helpful, but regulatory requirements remained ambiguous and examples of successful regulatory decisions based on RWE were limited. Payers mainly used RWE to supplement experimental evidence in coverage decisions, evaluated both types of evidence in similar ways, and had concerns about the rigor of RWE.Conclusions: Technical challenges may slow efforts to generate and use RWE in the near term. Additional regulatory guidance and examples, greater use of rigorous study designs and analytic methods, and continued stakeholder engagement could accelerate the use of RWE. [ABSTRACT FROM AUTHOR]

The safety, efficacy, and success of cochlear implants (CIs) are well established and have led to changes in criteria used by clinicians to determine who should receive a CI. Such changes in clinical decision-making have out-paced the slower-occurring changes that have taken place with regulatory bodies' and insurers' indications. We review the historical development of indications for CIs, including those of the U.S. Food and Drug Administration (FDA), Medicare, Medicaid, and private insurers. We report on expansion to include patients with greater residual hearing, such as those who receive Hybrid and EAS devices, and report on recent FDA approvals that place less emphasis on the patient's best-aided condition and greater emphasis on the ear to be treated. This includes expansion of CIs to patients with single-side deafness and asymmetric hearing loss. We review changes in the test materials used to determine candidacy, including transition from sentences in quiet to sentences in noise to the recent use of monosyllabic words and cognitive screening measures. Importantly, we discuss the recent trend to recommend CIs despite a patient not meeting FDA or insurers' indications (a practice known as "off-label"), which serves as attestation that current indications need to be updated. [ABSTRACT FROM AUTHOR]

Millions of consumer sport and fitness wearables (CSFWs) are used worldwide, and millions of datapoints are generated by each device. Moreover, these numbers are rapidly growing, and they contain a heterogeneity of devices, data types, and contexts for data collection. Companies and consumers would benefit from guiding standards on device quality and data formats. To address this growing need, we convened a virtual panel of industry and academic stakeholders, and this manuscript summarizes the outcomes of the discussion. Our objectives were to identify (1) key facilitators of and barriers to participation by CSFW manufacturers in guiding standards and (2) stakeholder priorities. The venues were the Yale Center for Biomedical Data Science Digital Health Monthly Seminar Series (62 participants) and the New England Chapter of the American College of Sports Medicine Annual Meeting (59 participants). In the discussion, stakeholders outlined both facilitators of (e.g., commercial return on investment in device quality, lucrative research partnerships, and transparent and multilevel evaluation of device quality) and barriers (e.g., competitive advantage conflict, lack of flexibility in previously developed devices) to participation in guiding standards. There was general agreement to adopt Keadle et al.'s standard pathway for testing devices (i.e., benchtop, laboratory, field-based, implementation) without consensus on the prioritization of these steps. Overall, there was enthusiasm not to add prescriptive or regulatory steps, but instead create a networking hub that connects companies to consumers and researchers for flexible guidance navigating the heterogeneity, multi-tiered development, dynamicity, and nebulousness of the CSFW field. [ABSTRACT FROM AUTHOR]

Objective: Patients fitted with a neurostimulator face a greater need to undergo magnetic resonance imaging (MRI) scans. Given the lack of literature in this regard, this study aims to review our experience with MRI examinations on patients implanted with a dorsal root ganglion stimulation (DRG‐S) system and their potential adverse events. Materials and Methods: We conducted a retrospective analysis of the prospective treatment documentation gathered from November 2011 to October 2020. We identified 259 MRI registrations for patients with an implanted neurostimulation system; the MRI examinations were performed using a 1.5 Tesla MRI system in accordance with a structured scheme. Results: Among the 259 MRI registrations identified in this study, 28 corresponded to patients with an implanted DRG‐S system. In 2 cases, no MRI scan was performed, and thus, only 26 MRI examinations were evaluated in detail. The DRG‐S device was approved for the requested MRI scans in only 2 of these 26 cases (7.7%). In addition, 2 minor adverse events (syncopal episode and connection problem) were identified, and only the second problem (3.8%) was related to neurostimulator operation. Conclusions: Necessary MRI examinations in patients with DRG‐S systems are rarely covered by the European CE/US Food and Drug Administration (CE/FDA) approval. Although the manufacturer recommendations are against the use of MRI in patients with implanted DRG‐S in certain conditions, we performed these scans without causing injury to the patient or damaging the device. Given that data on safety are limited, MRIs should be conducted study related. We provide recommendations for the procedure that should be followed when an MRI is needed urgently. [ABSTRACT FROM AUTHOR]

Over the past year, the Severe Acute Respiratory Syndrome Coronavirus 2 pandemic has led to rapid advancement regarding therapeutics, vaccines, and testing. In the United States, the Food and Drug Administration (FDA) is the agency ensuring standardization, reproducibility, and meeting benchmarks of safety and efficacy for these products. Among medical professionals and the public, there are often questions about the role of regulation, product development and approval, and terminology often used in regard to the FDA. This manuscript will serve as an introduction to the FDA, clarify the steps of drug development and approval, review terms related to product use, and discuss the role of the medical community and industry. The FDA serves as a regulatory agency ensuring safety, efficacy, and quality are met in the approval of drugs, vaccines, biologics, and testing products. Understanding the terms of development can help providers with many new products being developed. [ABSTRACT FROM AUTHOR]

The article presents the discussion on predicting the particulate respirator model which being the best fit in a particular population. Topics include using particulate respirators in healthcare increasing due to surgical masks providing barrier protection against droplets; and surgical masks not providing adequate protection against infectious respiratory diseases transmitting through droplets and aerosols.

Background: Anterior vertebral body tethering (aVBT) has emerged as a novel treatment option for patients with idiopathic scoliosis. We present the results from the first U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study on aVBT.Methods: In this prospective review of a retrospective data set, eligible patients underwent aVBT at a single center from August 2011 to July 2015. Inclusion criteria included skeletally immature patients with Lenke type-1A or 1B curves between 30° and 65°. Clinical and radiographic parameters were collected, with the latter measured by an independent reviewer.Results: Fifty-seven patients (49 girls and 8 boys), with a mean age (and standard deviation) of 12.4 ± 1.3 years (range, 10.1 to 15.0 years), were enrolled in the study. The patients had a mean of 7.5 ± 0.6 levels tethered, the mean operative time was 223 ± 79 minutes, and the mean estimated blood loss was 106 ± 86 mL. The patients were followed for an average of 55.2 ± 12.5 months and had a mean Risser grade of 4.2 ± 0.9 at the time of the latest follow-up. The main thoracic Cobb angle was a mean of 40.4° ± 6.8° preoperatively and was corrected to 18.7° ± 13.4° at the most recent follow-up. In the sagittal plane, T5-T12 kyphosis measured 15.5° ± 10.0° preoperatively, 17.0° ± 10.1° postoperatively, and 19.6° ± 12.7° at the most recent follow-up. Eighty percent of patients had curves of <30° at the most recent follow-up. The most recent Scoliosis Research Society (SRS) scores averaged 4.5 ± 0.4, and scores on the self-image questionnaire averaged 4.4 ± 0.7. No major neurologic or pulmonary complications occurred. Seven (12.3%) of 57 patients had a revision: 5 were done for overcorrection and 2, for adding-on.Conclusions: Anterior VBT is a promising technique that has emerged as a treatment option for patients with immature idiopathic scoliosis. We present the results from the first FDA-approved IDE study on aVBT, which formed the basis for the eventual Humanitarian Device Exemption approval. The findings affirm the safety and efficacy of this technique and suggest opportunities for improvement, particularly with respect to reoperation rates.Level Of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

The number of new medical devices cleared by the US Food and Drug Administration (FDA) through the 510(k) pathway that has subsequently been associated with safety risks has led to discussion of approaches to regulation and communication of device risks. As debate continues over whether the pathway needs to be altered, features of ethical use of 510(k)-cleared devices can include (1) heightened caution with respect to newly cleared 510(k) products until adequate data are gathered through postmarket surveillance, (2) facilitating informed consent by improving physician and patient knowledge of the 510(k) pathway, and (3) basing distribution of these devices on individual risk assessments while ensuring equitable access. [ABSTRACT FROM AUTHOR]

This article examines the history of device oversight by the US Food and Drug Administration (FDA). Significant regulatory changes occurred in response to injuries caused by Dalkon Shield intrauterine devices. This article summarizes those changes as well as continued efforts by the FDA to strengthen device oversight and address areas of concern. [ABSTRACT FROM AUTHOR]

Implantable brain-computer interface (BCI) and other devices with potential for both therapeutic purposes and human enhancement are being rapidly developed. The distinction between therapeutic and enhancement uses of these devices is not well defined. While the US Food and Drug Administration (FDA) rightly determines what is safe and effective, this article argues that the FDA should not make subjective, value-laden assessments about risks and benefits when it comes to approval of BCIs for therapy and enhancement. This article also argues that determining BCIs' benefits to society requires deliberations on values that the FDA is neither accustomed to making nor qualified to make. Given the inadequacy of the FDA's safe-and-effective standard to judge devices spanning the spectrum of therapy to enhancement, this article argues that BCI regulation should not be overseen by the FDA. [ABSTRACT FROM AUTHOR]

The article focuses on how Differently the FDA Regulate Drugs and Devices. Topics discussed include high-risk devices that are lifesaving or life-supporting are required to submit clinical data to demonstrate their safety and efficacy, also known as the premarket approval (PMA) pathway; and many devices are cleared through premarket notification (PMN), also known as the 510(k) pathway, which is permitted for low-to-moderate risk devices.

The regulatory landscape for device-based heart failure (HF) therapies has seen a major shift in the last 7 years. In 2013, the U.S. Food and Drug Administration released guidance for early feasibility and first-in-human studies, thereby encouraging device innovation, and in 2016 the U.S. Congress authorized the Breakthrough Devices Program to expedite access for Americans to innovative devices indicated for diagnosis and treatment of serious illnesses, such as HF. Since December 2016, there has been an increase in the number of HF devices for which manufacturers are seeking approval through the breakthrough designation pathway. This has led to a rapid uptake in the development and evaluation of device-based HF therapies. This article reviews the current and future landscape of device therapies for chronic HF and associated comorbidities and the regulatory environment that is driving current and future innovation. [ABSTRACT FROM AUTHOR]

Abstract: Orthopaedic device-related infection is one of the most devastating complications in orthopaedic and trauma surgery. With increasing life expectancies as well as the lifelong risk of bacterial seeding on an implant, the prevention and treatment of device-related infection remains an important area for research and development. To facilitate information exchange and enhance collaboration among various stakeholders in the orthopaedic community, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) organized an inaugural workshop on orthopaedic device-related infections, exploring the regulatory challenges that are faced when proceeding from the bench level to marketing and clinical implementation of new infection-control devices and products. This article summarizes the perspectives of scientists, clinicians, and industry partners on the current regulatory approval process for orthopaedic anti-infective technologies as well as the proposed strategies to overcome these regulatory challenges. [ABSTRACT FROM AUTHOR]

Importance: US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation.Objective: To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020.Evidence Review: Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry.Findings: Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are "substantially equivalent" to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products.Conclusions and Relevance: Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives: New therapies are increasingly approved by regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) based on testing in non‐randomized clinical trials. These treatments have typically displayed "dramatic effects" (ie, effects that are considered large enough to obviate the combined effects of biases and random errors that may affect the study results). The agencies, however, have not identified how large these effects should be to avoid the need for further testing in randomized controlled trials (RCTs). We investigated the effect size that would circumvent the need for further RCTs testing by the regulatory agencies. We hypothesized that the approval of therapeutic interventions by regulators is based on heuristic decision making whose accuracy can be best characterized by the application of signal detection theory (SDT). Methods: We merged the EMA and FDA database of approvals based on non‐RCT comparisons. We excluded duplicate entries between the two databases. We included a total of 134 approvals of drugs and devices based on non‐RCTs. We integrated Weber‐Fechner law of psychophysics and recognition heuristics within SDT to provide descriptive explanations of the decisions made by the FDA and EMA to approve new treatments based on non‐randomized studies without requiring further testing in RCTs. Results: Our findings suggest that when the difference between novel treatments and the historical control is at least one logarithm (base 10) of magnitude, the veracity of testing in non‐RCTs seems to be established. Conclusion: Drug developers and practitioners alike can use the change in one logarithm of effect size as a benchmark to decide if further testing in RCTs should be pursued, or as a guide to interpreting the results reported in non‐randomized studies. However, further research would be useful to better characterize the threshold of effect size above which testing in RCTs is not needed. [ABSTRACT FROM AUTHOR]

Background: The BIRMINGHAM HIP Resurfacing (BHR) system is a metal-on-metal hip implant system approved by the U.S. Food and Drug Administration in 2006. The approval required a multicenter, prospective, post-market-approval study. Our purpose is to report the current results at 10 years of follow-up.Methods: Between October 2006 and December 2009, 280 primary BHR procedures were performed at 5 sites. Outcome measures included Kaplan-Meier survivorship, reasons for revision, radiographic component stability and osteolysis, Harris hip scores, and metal levels including cobalt and chromium. The mean age at the time of the procedure was 51.3 ± 7.1 years, 74% (206) of 280 BHRs were implanted in male patients, the mean body mass index was 27.8 ± 4.4 kg/m2, and 95% (265) of 280 hips had a primary diagnosis of osteoarthritis. The mean follow-up among all 280 hips was 9.0 ± 2.5 years. Prior to 10-year follow-up, 20 hips were revised and 5 patients representing 5 hips had died. Among the remaining 255 hips, 218 (85%) met the minimum follow-up of 10 years.Results: The 10-year survival free from all-cause component revision was 92.9% (95% confidence interval [CI], 89.8% to 96.1%) for all hips and 96.0% (95% CI, 93.1% to 98.9%) among male patients <65 years old at the time of the procedure. Reasons for revision included femoral loosening (n = 5), femoral neck fracture (n = 3), pseudotumor (n = 3), osteolysis (n = 2), and acetabular loosening (n = 1), as well as 6 revisions for a combination of pain, noise, or metal levels. Among unrevised hips, the median Harris hip score improved from preoperatively (59) to 1 year postoperatively (99; p < 0.001) and remained stable through 10 years postoperatively (99; p = 0.08). Radiographically, 5% (10) of 218 unrevised hips had osteolysis with no component migration. Median metal levels had increased at 1 year postoperatively (cobalt: from 0.12 ppb preoperatively to 1.5 ppb at 1 year postoperatively, p < 0.001; chromium: from 0.6 ppb preoperatively to 1.7 ppb at 1 year postoperatively, p < 0.001), then remained stable through 5 years before slightly decreasing at 10 years postoperatively (cobalt: 1.3 ppb, p < 0.001; chromium: 1.4 ppb, p < 0.001).Conclusions: This prospective, multicenter, post-market-approval study demonstrated that the BHR implant system is safe and effective through 10 years of follow-up, particularly among young male patients.Level Of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]