RELEASE: Empatica Receives New FDA Clearance for Its Health Monitoring Platform and Announces a Fine

(Information sent by the signatory company).

RELEASE: Empatica Receives New FDA Clearance for Its Health Monitoring Platform and Announces a Fine

(Information sent by the signatory company)

BOSTON, Nov. 22, 2022 /PRNewswire/ -- Empatica, a digital health and AI company that develops medical-grade wearable devices and algorithms for health monitoring and diagnosis, today announced the authorization of its Empatica Health Monitoring Platform by the United States Food and Drug Administration (FDA).

The Empatica Health Monitoring Platform is a complete remote health monitoring and data collection solution for healthcare and research professionals, based on data collected by Empatica's CE-certified medical-grade EmbracePlus device . In addition, the platform includes Empatica's proprietary Care software suite, a secure cloud infrastructure, and clinically validated digital biomarkers.

Empatica's platform has been licensed for continuous data collection to monitor resting blood oxygen saturation (SpO2), peripheral skin temperature, sleep movement-associated activity, and electrodermal activity (EDA). . Each of Empatica's digital biomarkers is based on trained algorithms that analyze sensor data at 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 variability and respiratory rate.

The Empatica Health Monitoring Platform is being used worldwide by leading pharmaceutical companies to continuously collect and analyze physiological data for clinical trials evaluating the impact of new therapies, and Empatica is collaborating on the development of digital biomarkers for use as end points. Researchers also have the ability to develop their own digital biomarkers, which they can implement into their digital health applications or infrastructure using the platform's software development kit.

"This authorization represents an important step forward for our scientific community," said Dr. Marisa Cruz, Empatica's Chief Medical Officer. "Patients, healthcare professionals, and researchers deserve digital health products that are accurate, validated in diverse populations, and intuitive to use. We are proud to have built a solution that meets these goals, offering a high-quality digital health tool and trusted scientists working to improve patient outcomes through research and clinical care."

Today Empatica also announced the recent closing of its Series B financing, led by Sanofi Ventures and RA Capital, and with participation from Black Opal Ventures. The investment will enable Empatica to expand its suite of digital biomarkers, for use in patient care and as digital indicators in clinical trials.

"We are delighted to team up with Empatica, its investors and partners on this journey," said Cris De Luca, partner at Sanofi Ventures and newly appointed member of Empatica's board of directors. "By achieving greater resolution in disease symptomatology through novel digital measures and digital biomarkers in real-world and clinical settings, Empatica is unlocking the possibilities of early disease detection, improved treatment decisions, and improving the quality of life of patients around the world".

Empatica – www.empatica.comEmpatica Inc is a pioneer in AI-powered continuous and discrete 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, EmbracePlus, has been developed with key partners including HHS, USAMRDC, and NASA-funded TRISH.

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