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Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance

Leave a Comment / AI, cardiovascular, clinical trials, COPD, Digital Health, machine learning, Medical Device, MedTech, Product Design & Development, RC - Medical Device Audits, Certification & Verification, Real world data, SaMD / By

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance     This week Huma Therapeutics received 510(k) clearance for its configurable Software as a Medical Device (SaMD) disease management platform, which previously received Class IIb approval in the EU. The FDA Class II clearance allows users to add AI algorithms to the disease-agnostic platform, potentially speeding …

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Software and Artificial Intelligence as a Medical Device

Leave a Comment / AIaMD, artificial intelligence, device regulation, Digital Health, Medical Device, MedTech, MHRA, post market vigilance, Quality/Regulatory, SaMD / By

Software and Artificial Intelligence as a Medical Device     Earlier this month, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) issued the guidance document, “Software and Artificial Intelligence as a Medical Device.” The guidance brings together current guidances, advice and regulatory requirements for Software as a Medical Device (SaMD) and Artificial Intelligence as a …

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