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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What You Should Know:
– GE HealthCare has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its updated portfolio of Voluson™ Expert Series ultrasound systems.
– The Voluson Expert 22, 20,…
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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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Breaking News: FDA’s Landmark Decision
The Food and Drug Administration (FDA) made a groundbreaking announcement on January 15, 2025, revoking the authorization of Red No. 3 in food products and ingested medications. This decisive action…
Groundbreaking AI Healthcare Regulations Unveiled
The U.S. Food and Drug Administration (FDA) has initiated a transformative step in healthcare technology by releasing comprehensive draft guidance for AI-enabled medical devices on January 6, 2025. This pioneering…
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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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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