Latest EnsoData FDA 510(k) Clearance Enables AI-Powered Sleep Diagnosis Using Pulse Oximetry Devices

Latest EnsoData FDA 510(k) Clearance Enables AI-Powered Sleep Diagnosis Using Pulse Oximetry Devices

EnsoData, a pioneer in healthcare AI, achieved FDA 510(k) clearance for groundbreaking technology that enables AI-powered sleep diagnosis using FDA-cleared pulse oximetry (pulse ox) devices. Powered by EnsoSleep PPG scoring, widely available and wearable pulse ox technology can be deployed for a high quality, accessible, and cost-effective approach to diagnosing sleep disorders, including sleep apnea.

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