Empatica Receives FDA Approval for Two New Cardiac Digital Biomarkers

Cambridge, MA-based Empatica has received US FDA 510(k) clearance for two new digital biomarkers for its Empatica Health Monitoring Platform: pulse and respiratory rate.

With the addition of pulse and respiratory rate, the Empatica Health Monitoring Platform now includes six FDA-cleared digital biomarkers, among the most offered for use in clinical trials. These are among the 128 digital measures supported by the platform, the largest offering available in a single solution, delivering confidence to a broad spectrum of health care professionals and researchers seeking to validate treatments, better understand diseases, and innovate to improve health outcomes.

The Empatica Health Monitoring Platform is a full-stack remote health monitoring and data collection solution for researchers 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.

We are pleased to receive these two additional FDA-cleared biomarkers, pulse rate and respiratory rate, and 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,” said Marisa Cruz, Chief Medical Officer at Empatica.

One thought on “Empatica Receives FDA Approval for Two New Cardiac Digital Biomarkers

Comments are closed.

en_GBEnglish (UK)