Industry news in brief

This Digital Health News industry roundup includes an IT award for the Department of Health and Social Care and Netcompany for the NHS Covid Pass, accreditation for an AI device and a virtual falls service keeping care home residents out of hospital.

Empatica receives FDA clearance and announces Series B financing

Digital health and AI company Empatica has received clearance of its Empatica Health Monitoring Platform by the US Food and Drug Administration (FDA).

The platform has been cleared for continuous data collection to monitor blood oxygen saturation during rest, peripheral skin temperature, activity associated with movement during sleep and electrodermal activity. Each digital biomarker is based on trained algorithms that analyse sensor data in one-minute intervals.

Dr. Marisa Cruz, chief medical officer of Empatica, said: “This clearance represents a significant step forward for our scientific community. 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 built a solution that accomplishes these goals, offering a high-quality and reliable digital health tool to scientists working to improve patient outcomes through research and clinical care.”

The company has also announced the closing of its Series B financing. The investment was led by Sanofi Venture and RA Capital Management with participation by Black Opal Ventures.

Empatica intends to use the financing to expand its suite of digital biomarkers for use in both patient care and in clinical trials as digital endpoints.

Cris De Luca, partner at Sanofi Ventures and newly-appointed board member at Empatica, said: “By gaining higher resolution into disease symptomology through novel digital measures and digital biomarkers in clinical and real-world settings, Empatica is unlocking the possibilities of early disease detection, enhanced treatment decisions, and improving quality of life for patients around the world.”

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