Empatica’s Cardiac Digital Biomarkers Granted Fresh FDA Clearance

By June Alluree

Empatica a leading digital health and artificial intelligence (AI) company specializing in the development of medical-grade smart wearables and digital biomarkers for health monitoring and diagnostics, has recently received clearance from the U.S. Food and Drug Administration (FDA) for two new digital biomarkers within its Empatica Health Monitoring Platform. These innovative additions encompass pulse rate and respiratory rate.

With the introduction of pulse rate and respiratory rate, the Empatica Health Monitoring Platform now boasts a total of six FDA-cleared digital biomarkers. This achievement places Empatica at the forefront of digital health solutions for clinical trials. Notably, these two biomarkers are part of a comprehensive array of 128 digital metrics offered by the platform, representing one of the most extensive selections available in a single solution. This wealth of data empowers healthcare professionals and researchers alike, providing them with the tools needed to validate treatments, gain a deeper understanding of diseases, and drive innovation in healthcare for improved patient outcomes.

Dr. Marisa Cruz, Chief Medical Officer of Empatica, expressed her enthusiasm for this milestone, stating, “We are excited to announce the expansion of our Empatica medical monitoring platform to two additional FDA-cleared biomarkers, pulse rate and respiratory rate. This approval reflects our ongoing commitment to rigorous analytical and clinical validation of digital biomarkers for clinical research and patient care. The Empatica medical monitoring platform is a prime example of how dependable, precise, and user-friendly technology can foster the development of new therapies and enhance patient outcomes.”

Empatica’s medical monitoring platform offers a comprehensive solution for remote health monitoring and data collection, catering to the needs of both research and healthcare professionals. It is anchored in data collected by Empatica’s medical-grade EmbracePlus smartwatch. In addition to the EmbracePlus smart accessory, the Empatica medical monitoring platform encompasses Empatica’s Care software suite, a secure cloud infrastructure, and a range of clinically validated digital biomarkers.

The FDA initially authorized the Empatica medical monitoring platform in November 2022. This initial clearance included clinically validated digital biomarkers for monitoring electrodermal activity, blood oxygen saturation (SpO2), skin temperature, and sleep movement. Beyond the metrics authorized by the FDA, the platform offers access to raw data from EmbracePlus sensors and over 100 science-grade biomarkers, making it an exceptionally high-performance and adaptable tool for today’s clinicians and researchers. This comprehensive suite of digital biomarkers and data capabilities positions Empatica as a key player in advancing the field of digital health and healthcare research.