Empatica is proud to announce US Food and Drug Administration (FDA) 510(k) clearance for two new digital biomarkers for our 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 healthcare professionals and researchers as they seek to validate treatments, better understand diseases, and innovate to improve health outcomes.
In the words of our Chief Medical Officer, Marisa Cruz, “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.”
