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Empatica Health Monitoring Platform Receives FDA Clearance


Empatica, a digital health and AI company developing medical-grade wearables and algorithms for health monitoring and diagnostics, announced the clearance of its Empatica Health Monitoring Platform by the FDA for data collection for the continuous monitoring of SpO2, Electrodermal Activity, Skin Temperature and activity associated with movement during sleep.

Each of Empatica's digital biomarkers is based on trained algorithms that analyze sensor data in one-minute intervals, and has been validated in clinical studies conducted with diverse groups of participants. Platform users can also access raw data collected by EmbracePlus' five sensors, and research-grade digital biomarkers such as Pulse Rate, Pulse Rate Variability, and Respiratory Rate.

Read the full press release.

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