The US Food and Drug Administration (FDA) has granted Empatica 510(k) clearance for two new digital biomarkers for its Empatica Health Monitoring Platform: respiratory rate and pulse.

With the addition of respiratory rate and pulse, the Empatica Health Monitoring Platform now includes six FDA-cleared digital biomarkers. These are among the 128 digital measures supported by the platform.

“This clearance reflects our continued commitment to rigorous analytical and clinical validation of digital biomarkers for use in clinical research and patient care,” says Marisa Cruz, chief medical officer at Empatica, in a release. “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 solution for research and healthcare professionals, built on data collected by the company’s medical-grade EmbracePlus wearable. In addition to the EmbracePlus wearable, the Empatica Health Monitoring Platform also includes Empatica’s proprietary Care software suite, secure cloud infrastructure, and clinically validated digital biomarkers.

The Empatica Health Monitoring Platform received its initial FDA clearance in November 2022. Included within that clearance were clinically validated digital biomarkers used to monitor electrodermal activity, SpO2, skin temperature, and movement during sleep. 

Beyond the FDA-cleared measures provided, the Empatica Health Monitoring Platform also offers access to raw data from the EmbracePlus sensors, and over 100 research-grade biomarkers.

Photo caption: Empatica receives FDA 510(k) clearance for two new digital biomarkers for its Empatica Health Monitoring Platform

Photo credit: Empatica