Empatica's platform receives new FDA approval for digital cardiac biomarkers
14.11.2023 14:55
Empatica, a digital health and AI company developing medical wearables and digital biomarkers for health monitoring and diagnostics, announced the US Food and Drug Administration's release of its two new digital biomarkers for pulse and respiratory rate as part of the Empatica Health Monitoring Platform and Drug Administration (FDA) in accordance with the 510(k) standard.
With the addition of pulse and respiratory rate, the Empatica Health Monitoring Platform now includes six FDA-approved digital biomarkers, which are among the most commonly offered biomarkers for use in clinical trials. These biomarkers are among the 128 digital measurements supported by the platform. This makes the platform the most comprehensive offering available in a single solution that a wide range of healthcare professionals and researchers can rely on to validate treatments, better understand disease and innovate to improve health outcomes.
“We are pleased to announce the expansion of our Empatica Health Monitoring Platform to include two additional FDA-approved biomarkers, pulse rate and respiratory rate,” announced Marisa Cruz, Chief Medical Officer at Empatica. “This approval reflects our ongoing 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 the development of new therapeutics and improve patient outcomes.”
The Empatica Health Monitoring Platform is a comprehensive remote health monitoring and data collection solution for research and healthcare professionals based on data collected by EmbracePlus, the company's medical device certified 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 first FDA approval in November 2022. This approval included clinically validated digital biomarkers used to monitor electrodermal activity, blood oxygen saturation (SpO2), skin temperature and movement during sleep. Beyond the FDA-approved measurements provided, the Empatica Health Monitoring Platform also provides access to raw data from the EmbracePlus sensors and over 100 research-grade biomarkers, making it a powerful and versatile measurement tool for today's clinicians and researchers.