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2 results for “device” in Newsroom

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Industry news | 27 February, 2024
EnsoData’s AI-powered sleep study diagnostic gets FDA 510(k) clearance

EnsoData has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its machine learning-based diagnostic for sleep apnea and other sleep disorders that uses data from pulse oximetry (pulse ox) devices.
Industry news | 06 March, 2023
FDA Breakthrough Device v.s. NMPA Innovative Medical Device

Recently, U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) have released their summaries on medical device innovation in 2022.

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2 results for “device” in Newsroom

EnsoData’s AI-powered sleep study diagnostic gets FDA 510(k) clearance

FDA Breakthrough Device v.s. NMPA Innovative Medical Device

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