The Food and Drug Administration (FDA) published new draft guidelines aimed at improving the accuracy and performance of pulse oximeters by considering the range of skin tones.The guidance, Pulse Oximeters for Medical Purposes -…
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An increasing number of health systems are hiring executives, usually physicians, to head their artificial intelligence efforts – often chief AI officers, fully at the C-suite level. The complex technology with great potential is…
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The U.S. Food and Drug Administration is seeking public comment on new recommendations for non-clinical and clinical performance testing to support premarket submissions for pulse oximeters for medical purposes. These include devices with a…
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Essential FDA Guidelines Transform AI Medical Devices
Revolutionary Changes in Medical Device Regulation
The U.S. Food and Drug Administration is introducing groundbreaking marketing submission recommendations for AI-enhanced medical devices. These guidelines will provide comprehensive oversight throughout…
Essential DoD GenAI Testing Breakthrough Revealed
Revolutionary Testing Program Overview
The U.S. Department of Defense’s Chief Digital and Artificial Intelligence Office, in collaboration with Humane Intelligence, has successfully concluded their Crowdsourced Artificial Intelligence Red-Teaming Assurance Program…
What You Should Know:
– Wellumio, a New Zealand-based medical device innovator announced the launch of a new subsidiary in California, a strategic move aimed at facilitating US-based clinical trials for its groundbreaking Axana device…
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Dr. Arti Masturzo, Chief Medical Officer at CCS
The conversation about what makes a “healthy” body has never been simple. Throughout every era of history, people have resorted to calling each other too fat, too thin,…
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Philipp Buschmann, co-founder and CEO of AAZZUR
Healthcare has dramatically transformed in recent years, driven by the urgent need to keep pace with an increasingly fast-moving world. With technology leading the way, healthcare providers, insurers,…
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To support the continued development and marketing of safe and effective medical devices enhanced by artificial intelligence, the U.S. Food and Drug Administration will offer marketing submission recommendations, including the documentation and information needed…
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The Department for Health and Social Care (DHSC) has revealed it will develop a shared digital platform to allow up-to-date medical information to be shared between NHS and care staff.
The announcement by health secretary…
