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Empatica's Innovative Platform Secures FDA Approval for Advanced Cardiac Digital Biomarkers

Friday, November 03, 2023

Empatica, a prominent player in the digital health and AI sector, focusing on the development of medical-grade wearables and digital biomarkers for health monitoring and diagnostic purposes, has recently received FDA 510(k) clearance for two innovative digital biomarkers integrated into its Empatica Health Monitoring Platform: specifically, pulse and respiratory rate. This significant regulatory milestone now bolsters the Empatica Health Monitoring Platform with a total of six FDA-approved digital biomarkers, placing it among the most comprehensive options available for clinical research trials. Notably, the platform encompasses an extensive range of 128 digital metrics, offering the broad healthcare and research communities a rich resource to validate treatments, enhance disease understanding, and drive innovations for improved health outcomes.

Expressing the company's commitment, a representative from Empatica remarked, "This clearance underscores our ongoing dedication to rigorously validating digital biomarkers for application in both clinical research and patient care. The Empatica Health Monitoring Platform exemplifies how reliable, precise, and user-friendly technology can significantly advance the development of cutting-edge therapeutics and contribute to better patient outcomes."

The Empatica Health Monitoring Platform is an end-to-end solution for remote health monitoring and data collection, tailored for use by healthcare professionals and researchers. The platform leverages data gathered through Empatica's EmbracePlus wearable, renowned for its medical-grade accuracy. Alongside the EmbracePlus wearable, the Empatica Health Monitoring Platform incorporates the proprietary Care software suite, a secure cloud infrastructure, and a range of clinically validated digital biomarkers.

Source: prnewswire.com


 

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