This project represents the first systematic assessment of the US Food and Drug Administration’s postmarket surveillance of legally marketed artificial intelligence and machine learning based medical devices. We focus on the Manufacturer and User…
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FaceHeart from Taiwan has obtained regulatory approval in the United States for its AI-driven contactless technology for measuring respiratory rate. It obtained a 510(k) clearance from the US Food and Drug Administration for the respiratory…
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Welcome to the January edition of Digital Health Digest, your trusted source for the latest in digital health and healthcare technology!In this episode, we cover major updates transforming the digital health landscape—from Bicycle Health…
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Hong Kong-based startup PanopticAI has obtained regulatory approval in the United States for its contactless pulse rate measuring application. It received the US Food and Drug Administration’s 510(k) clearance for the PanopticAI Vital Signs app…
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A South Korean manufacturer which claims to develop the world’s first AI-powered doll companion for seniors has recently registered its product in the United States. Hyodol has recently announced that its AI companion doll of…
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South Korean medical imaging AI company Neurophet has received second clearance for its brain image analysis software in the United States.It obtained another 510(k) from the US Food and Drug Administration for the latest…
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It’s not an easy question to answer, but with a well thought out roadmap, it’s doable.
By John Halamka, M.D., President, Mayo Clinic Platform and Paul Cerrato, MA, senior research analyst and communications specialist, Mayo…
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Former US Food and Drug Administration Commissioner Scott Gottlieb, MD published a call to action this week in JAMA Health Forum that asks Congress to update FDA regulations for medical AI. He begins the…
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The Medicines and Healthcare products Regulatory Agency (MHRA) has published guiding principles for machine learning medical devices focusing on transparency.The guidance on the transparency of machine learning medical devices, published on 13 June 2024,…
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What You Should Know:
– Samsung’s Galaxy Watch has received De Novo authorization from the US Food and Drug Administration (FDA) for its sleep apnea detection feature.
– This marks a significant step forward in wearable…
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