The Medicines and Healthcare products Regulatory Agency (MHRA) has selected five technologies for its AI Airlock, a pilot scheme launched to better understand how we can regulate AI powered medical devices.
AI Airlock, which launched…
It is bittersweet that the annual RSNA conference is coming to a close #rsna24The highlight of today was connecting with Dr. Ravi Bickram Shrestha from Canon Medical Systems. He walked us through the entire…
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The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing AI-enabled medical devices.”This final guidance is part…
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Welcome to the November edition of Digital Health Digest!In this episode, we cover key updates in digital health, including innovative AI patents, advancements in remote patient monitoring, and the latest global strategies for transforming…
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The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software…
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What You Should Know:
– Today, connected fitness startup GROWL emerged from stealth to unveil a groundbreaking product: a boxing bag transformed into a personal, at-home boxing & fitness coach. The product goes beyond traditional fitness devices, offering…
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The European Union (EU) Medical Device Regulation and In Vitro Medical Device Regulation have introduced more rigorous regulatory requirements for medical devices, including new rules for post-market surveillance. However, EU market vigilance is limited…
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Andrew Spier, Vice President of Advanced Cyber Solutions and Commercial Services at Core4ce
Recent and high-profile cyber, ransomware and supply chain attacks on Kaiser Permanente, Ascension, and Change Healthcare have shown how the healthcare industry…
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Researchers from South Korea have built machine learning-based models that can predict mood episodes using only sleep and circadian rhythm data from wearable devices. The team comprised researchers from the Institute for Basic Sciences (IBS),…
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Zac Amos, Features Editor at ReHack
Remote patient monitoring systems have unlocked new standards of care. They can reduce lines in hospital waiting rooms, streamline checkups and enable fast, personalized treatments for improved health outcomes….
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