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How digital therapies can transform your health.Traditional health care has a new ally. Some patients with sleep disorders, back pain, and diabetes are now being prescribed app-based treatment instead of drugs. Algorithms are helping cancer patients manage their symptoms, and video games are improving the attention span of children diagnosed with ADHD. A new class of medicine called digital therapeutics (DTx) is gaining traction and transforming the way patients engage with the health care system. In Medicine without Meds, Dean Ho, Yoann Sapanel, and Agata Blasiak explore the exciting potential for these digital therapies to transform patient care.Ho, Sapanel, and Blasiak share their insights on how these therapies can deliver value beyond the technology, address the challenges of implementation in existing health care models, and revolutionize care delivery. These clinicians, researchers, engineers, patients, start-up founders, and corporate executives are at the forefront of designing and building tomorrow's DTx. They explain what DTx represents, how it differs from other digital health solutions, and how these tools can be conceptualized, created, and brought to market. Throughout, case studies from leading DTx organization such as Akili Interactive, MedRhythms, and Welldoc illuminate best practices in product development, issues to consider, and pitfalls to avoid. These essays, along with a foreword by D. A. Wallach and Dr. Eddie Martucci's outlook on the future of DTx, present the exciting potential for DTx to reimagine health care for all.

High profile device failures have highlighted the inadequacies of current regulation. Art Sedrakyan and colleagues call for a move to a graduated model of approval and suggest a framework to achieve this goal

As compared with Europe, the United States generally requires more rigorous clinical testing of high-risk devices, which delays patients' access to new devices but may provide better assurance of device safety. Millions of patients worldwide depend on an ever-widening array of medical devices for the diagnosis and management of disease. In the United States, the Food and Drug Administration (FDA) requires manufacturers of high-risk devices such as heart valves and intraocular lens implants to demonstrate safety and effectiveness before the devices can be marketed. However, some policymakers and device manufacturers have characterized U.S. device regulation as slow, risk-averse, and expensive. 1 , 2 Other experts, such as those at the Institute of Medicine, have suggested that current premarketing procedures may not be comprehensive enough and may be particularly dangerous for devices that have . . .

This article calls attention to an open public comment period regarding a proposed new rule from the Department of Health and Human Services that affects clinical trial registration and results reporting. Broad access to information about clinical trials and their findings is critical for advancing medicine, promoting public health, and fulfilling ethical obligations to human volunteers. 1 Traditional methods of information dissemination (e.g., presentations and publication) may nevertheless leave distortions and gaps in the knowledge base because the results of many trials are not published. 2 – 4 Title VIII of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA) 5 addressed some of these concerns by requiring the registration and submission of summary results information to ClinicalTrials.gov for certain clinical trials of drugs (including biologic products) and devices. The Department of Health . . .

CMS recently finalized a rule that could substantially alter Medicare-coverage decisions for certain new medical devices. The rule is intended to expedite coverage, but it would undermine Medicare’s authority to consider the clinical evidence supporting device adoption.

The interaction between patents and FDA’s De Novo and 510(k) regulatory pathways has the potential to threaten follow-on innovation for medical devices.

BackgroundThe evolution of neuroendovascular technologies has progressed substantially. Over the last two decades, the introduction of new endovascular devices has facilitated treatment for more patients, and as a result, the regulatory environment concerning neuroendovascular devices has evolved rapidly in response.ObjectiveTo examine trends in the approval of neuroendovascular devices by the United States Food and Drug Administration (FDA) over the last 20 years.MethodsOpen-access US FDA databases were queried between January 2000 and December 2022 for all devices approved by the Neurological Devices Advisory Committee. Neuroendovascular devices were manually classified and grouped by category. Device approval data, including approval times, approval pathway, and presence of predicate devices, were examined.ResultsA total of 3186 neurological devices were approved via various US FDA pathways during the study period. 320 (10.0%) corresponded to neuroendovascular devices, of which 301 (94.1%) were approved via the 510(k) pathway. The percentage of 510(k) pathway neuroendovascular devices increased from 6.9% to 14.3% of all neuro devices before and after 2015, respectively. There was an increase in approval times for neuroendovascular devices cleared after 2015.ConclusionOver the last two decades, the neuroendovascular device armamentarium has rapidly expanded, especially after positive stroke trials in 2015. Regulatory approval times are significantly affected by device category, generation, company size, and company location, and a vast majority are approved by the 510(k) pathway. These results can guide further innovation in the endovascular device space and may act as a roadmap for future regulatory planning.

Context: Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients. Methods: We explored and analyzed medical device regulatory systems in the United States and Europe in accordance with the available gray and peer-reviewed literature and legislative documents. Findings: The two regulatory systems differ in their mandate and orientation, organization, pre- and postmarket evidence requirements, and transparency of process. Despite these differences, both jurisdictions face similar challenges for ensuring that only safe and effective devices reach the market, monitoring real-world use, and exchanging pertinent information on devices with key users such as clinicians and patients. To address these issues, reforms have recently been introduced or debated in the United States and Europe that are principally focused on strengthening regulatory processes, enhancing postmarket regulation through more robust surveillance systems, and improving the traceability and monitoring of devices. Some changes in premarket requirements for devices are being considered. Conclusions: Although the current reforms address some of the outstanding challenges in device regulation, additional steps are needed to improve existing policy. We examine a number of actions to be considered, such as requiring high-quality evidence of benefit for medium- and high-risk devices; moving toward greater centralization and coordination of regulatory approval in Europe; creating links between device identifier systems and existing data collection tools, such as electronic health records; and fostering increased and more effective use of registries to ensure safe postmarket use of new and existing devices.

In June 2017, the Food and Drug Administration (FDA) approved a new indication for use of the Edwards Sapien 3 transcatheter heart valve (Edwards Lifesciences, Irvine, California), 2 years after the initial approval of the device. This approval was unique because the underlying evidence was generated from a postmarket registry of patients receiving transcatheter aortic valve replacement, not from premarket clinical trials. Registries, along with electronic health records (EHRs) and claims data, are among the many data sources generated outside of traditional clinical research settings being used for real-world evidence (RWE).1 Such RWE-based approvals represent not only the future of generating evidence of the benefits and risks of medical products to inform regulatory approvals, but also decisions by payers, patients, and clinicians. Accordingly, to ensure that this evidence is rigorous and reliable, steps must be taken to require registration and results reporting of all RWE studies of FDA-regulated products.Such calls have been made previously for all observational studies,2-4 but recent changes at FDA heighten its pertinence for RWE studies. In 2017, FDA's Center for Devices and Radiologic Health (CDRH) released a Guidance Document entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. In December 2018, FDA met the 21st Century Cures Act provisions specifying that the agency create a program to evaluate use of RWE \"to help support the approval of a new indication for a drug already approved ... or to help support or satisfy drug postapproval study requirements.\"5 FDA has been shifting toward a life-cycle approach to medical product evaluation, increasingly relying on safety and effectiveness evaluations after market approval, as opposed to premarket, to facilitate earlier patient access to novel medical products.

The globalization and rapid advancements in medical technologies necessitate the harmonization of international regulatory frameworks to ensure the efficient and timely clinical application of medical products, including pharmaceuticals and medical devices. Regulatory reliance, a critical component of this harmonization process, is a powerful tool that provides efficient access for economic entities and regulatory authorities, promoting predictable decision-making and accelerating approvals. The Medical Device Single Audit Program (MDSAP) serves as a regulatory reliance framework for medical device inspections. Implemented by countries including Japan, the United States, Canada, Australia, and Brazil, MDSAP allows third-party certification bodies, recognized by these regulatory authorities, to conduct audits on medical device manufacturers. The outcomes of these audits are shared with the regulatory authorities, who use them for regulatory assessments and decision-making. Since transitioning to its implementation phase in 2017, MDSAP has been widely utilized in various countries. This review provides an overview of the adoption and utilization of MDSAP in major countries, exploring the program’s impact on regulatory processes and its potential as a method of regulatory reliance to facilitate timely access to effective and safe medical devices.