Empatica, a digital health and AI company specialising in medical-grade wearables and digital biomarkers for health monitoring and diagnostics, recently obtained FDA 510(k) clearance for two new digital biomarkers: pulse rate and respiratory rate.
This development enhances the Empatica Health Monitoring Platform, which now encompasses six FDA-cleared digital biomarkers among its impressive array of 128 supported measures. It stands out as one of the most comprehensive solutions available for clinical trials and healthcare research, providing professionals with the tools they need to validate treatments and enhance health outcomes.
Marisa Cruz, Empatica's Chief Medical Officer, highlighted the company's unwavering commitment to rigorous validation and its pivotal role in supporting clinical research and patient care.
The Empatica Health Monitoring Platform is a complete solution that leverages the EmbracePlus wearable for data collection, supplemented by Empatica's Care software suite, secure cloud infrastructure, and a range of clinically validated digital biomarkers.
This expansion comes on the heels of the initial FDA clearance achieved in November 2022, solidifying the platform's status as a versatile and valuable tool for clinicians and researchers, offering both FDA-cleared and research-grade biomarkers.
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