US-based digital health and AI company Empatica has received the US Food and Drug Administration (FDA) approval for its remote health monitoring and data collection solution, dubbed Empatica Health Monitoring Platform, for research and healthcare professionals.

The solution is created based on data collected by the company’s medical-grade, CE mark-approved EmbracePlus wearable.

The US FDA indicated Empatica’s Platform for continuous monitoring of blood oxygen saturation (SpO2) during rest, peripheral skin temperature, movement during sleep, and Electrodermal Activity (EDA).

In addition, the platform includes its Care software suite, secure cloud infrastructure, and clinically validated digital biomarkers, said the company.

Empatica chief medical officer Marisa Cruz 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 digital biomarkers used in the Empatica Health Monitoring Platform run on trained algorithms that analyse sensor data in one-minute intervals.

The biomarkers have been validated in clinical studies conducted in diverse groups of participants, said the company.

Individuals using the platform can also access raw data collected by EmbracePlus’ sensors and digital biomarkers, including pulse rate, pulse rate variability, and respiratory rate.

In addition, Empatica has announced the closing of a Series B financing round, led by Sanofi Ventures and RA Capital Management, with participation from Black Opal Ventures.

The company intends to use the investment to expand its suite of digital biomarkers, for use in patient care and as digital endpoints in clinical trials.

Sanofi Ventures partner and Empatica board member Cris De Luca said: “We are excited to team up with Empatica, their investors and partners on this journey.

“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.”