The following is a guest article by Alex Rybak, Senior Director of Product Management at Revenera
Pacemakers, insulin pumps, CT systems, wearables; these and many more medical devices are increasingly common parts of contemporary healthcare…
Machine learning and artificial intelligence (AI/ML) models in healthcare may exacerbate health biases. Regulatory oversight is critical in evaluating the safety and effectiveness of AI/ML devices in clinical settings. We conducted a scoping review…
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News
Microsoft releases a major enhancement to Copilot that adds conversational capabilities, a virtual news presenter that will read headlines, webpage history recall, and the ability to answer questions about the text and images on…
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Digital medical devices (DMDs) present unique opportunities in their regulation and reimbursement. A dynamic landscape of DMD assessment frameworks is emerging within the European Union, with five clusters of prevailing approaches identified. Despite notable…
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This paper focuses on how regulatory bodies respond to artificial intelligence (AI)-enabled medical devices. To achieve this, we present a comparative overview of the United States (USA), European Union (EU), and China. Our search…
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For years, I’ve watched promising medical technologies languish in labs, never reaching the patients who desperately need them. The culprit? Not overzealous regulators, but our antiquated approach to innovation. It’s time we stop pointing…
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You’ve heard the saying before, time and time again: sleep occupies nearly a third of our lives. From memory formation, concentration to overall wellness, the power of how we spend that 30 percent of…
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Home blood glucose monitoring was first introduced in 1980. While there were initially hurdles to overcome related to accuracy and cost, a consistent hurdle since that time has been efficient data sharing between patients…
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Neeraj Mainkar, VP of Software Engineering & Advanced Technology at Proprio
In healthcare, the impact of well-designed medical devices reaches far beyond their physical form. When these devices are thoughtfully crafted with the end-user in…
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The U.S. Department of Health and Human Services on Thursday announced new funding to help improve the use and maintenance of artificial intelligence-enabled medical devices.Research has shown that machine learning models used in clinical…
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