FDA OKs Cardiac Digital Biomarkers for Empatica’s Health Monitoring Platform

Empatica, a digital health and artificial intelligence (AI) company developing medical-grade wearables and digital biomarkers, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for two new digital biomarkers for its Empatica Health Monitoring Platform: pulse and respiratory rate.
 
By adding pulse and respiratory rate, Empatica’s platform includes six FDA-cleared digital biomarkers. The company said these are among the 128 digital measures the platform supports, the largest offering available in a single solution.
 
“We are delighted to announce the expansion of our Empatica Health Monitoring Platform to encompass two additional FDA-cleared biomarkers, pulse rate and respiratory rate,” Empactica’s chief medical officer Marisa Cruz told the press. “This clearance reflects our continued commitment to rigorous analytical and clinical validation of digital biomarkers for use in clinical research and patient care. The Empatica Health Monitoring Platform is a leading example of how reliable, accurate, and intuitive technology can support development of novel therapeutics and improve patient outcomes.”
 
The Empatica Health Monitoring Platform is a full-stack remote health monitoring and data collection tool for research and healthcare professionals, built on data collected by the company’s EmbracePlus wearable. The platform also includes the company’s Care software suite, secure cloud infrastructure, and clinically validated digital biomarkers.
 
The platform earned its first FDA clearance in November 2022, which included digital biomarkers to monitoring electrodermal activity, SpO₂, skin temperature, and movement during sleep.