BOSTON, November 22, 2022 /PRNewswire/ — Empatica, a digital health and artificial intelligence company developing wearables and medical-grade algorithms for health monitoring and diagnostics, today announced the clearance of its monitoring platform of Empatica Health by the United States Food and Drug Administration (FDA).
Empatica’s Health Monitoring Platform is a complete remote health monitoring and data collection solution for research and healthcare professionals, based on data collected by the quality EmbracePlus wearable medical and CE certified from Empatica. Additionally, the platform includes Empatica’s proprietary Care software suite, secure cloud infrastructure, and clinically validated digital biomarkers.
Empatica’s platform has been cleared for continuous data collection to monitor blood oxygen saturation (SpO2) during rest, peripheral skin temperature, movement-associated activity during sleep, and activity electrodermal (EDA). Each of Empatica’s digital biomarkers are based on trained algorithms that analyze sensor data at one-minute intervals, and have been rigorously validated in clinical studies conducted with diverse groups of participants. Platform users can also access raw data collected by EmbracePlus’ five sensors and research-grade digital biomarkers such as pulse rate, pulse rate variability, and respiratory rate.
The Empatica health monitoring platform is used worldwide by major pharmaceutical companies to continuously collect and analyze physiological data for clinical trials evaluating the impact of new therapies, with Empatica collaborating to develop digital biomarkers to use as parameters. Researchers also have the ability to develop their own digital biomarkers, which they can implement in their digital health applications or infrastructure using the platform’s software development kit.
“This clearance represents a significant step forward for our scientific community,” said Dr. Marisa Cruz, Empatica’s Chief Medical Officer. “Patients, healthcare providers and researchers deserve digital health products that are accurate, validated in diverse populations and intuitive to use. We are proud to have designed a solution that achieves these goals, delivering a digital health tool reliable and high quality for scientists working to improve patient outcomes through research and clinical care.”
Today, Empatica also announced the recent closing of its Series B funding, led by Sanofi Ventures and RA Capital Management, and the participation of Black Opal Ventures.. The investment will allow Empatica to expand its suite of digital biomarkers, for use in patient care and as digital endpoints in clinical trials.
“We are thrilled to team up with Empatica, their investors and partners on this journey,” said Cris DeLuca, Partner at Sanofi Ventures and newly appointed board member of Empatica. “By achieving higher resolution of disease symptomatology through novel digital metrics and digital biomarkers in clinical and real-world settings, Empatica opens up the possibilities for early disease detection, improved treatment decisions, and improving the quality of life of patients around the world.
Empatica – www.empatica.com
Empatica Inc is a pioneer in continuous, unobtrusive AI-driven remote health monitoring. Empatica’s platform and technology are used by thousands of institutional partners for research purposes, in studies examining stress, sleep, epilepsy, migraine, depression, addiction and other conditions. Its flagship wearable medical product, EmbracePlus, was developed with key partners including HHS, USAMRDC and NASA-funded TRISH.
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