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…
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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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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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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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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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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Vuno receives second 510(k)South Korean medical AI company Vuno has obtained a 510(k) clearance from the United States Food and Drug Administration for its chest X-ray analysis AI software.
The VunoMed Chest X-ray Triage quickly…
In a letter to Dr. Michelle Tarver, newly appointed director of the Center for Devices and Radiological Health, a division of the Food and Drug Administration, seven members of Congress have asked the agency…
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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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