Empatica Awarded New FDA Clearance for Cardiac Digital Biomarkers

Empatica receives US Food and Drug Administration (FDA) 510(k) clearance for two new digital biomarkers for its Empatica Health Monitoring Platform

What You Should Know:

– Empatica, a digital health and AI company, has obtained FDA 510(k) clearance for two new digital biomarkers, pulse rate, and respiratory rate, on its Empatica Health Monitoring Platform.

– This clearance expands the platform to include a total of six FDA-cleared digital biomarkers, out of the 128 digital measures supported, making it one of the most comprehensive solutions available for use in clinical trials.

– The Empatica Health Monitoring Platform comprises a complete remote health monitoring and data collection solution designed for research and healthcare professionals, utilizing data from the company’s medical-grade EmbracePlus wearable. In addition to the EmbracePlus wearable, the platform includes Empatica’s proprietary Care software suite, secure cloud infrastructure, and clinically validated digital biomarkers.

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