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.
