Media Lab spinoff Empatica, a digital health and AI company co-founded by Professor Rosalind Picard, has announced the clearance of its Empatica Health Monitoring Platform by the US Food and Drug Administration (FDA).

The Empatica Health Monitoring Platform can accelerate the development of novel therapeutics and the adoption of digital endpoints in patient care and clinical trials. The FDA clearance includes data collection for the continuous monitoring of SpO2, electrodermal activity, skin temperature, and activity associated with movement during sleep.

Empatica also announced the completion of its Series B financing, led by Sanofi Ventures and RA Capital Management, and participation by Black Opal Ventures. The investment will enable Empatica, which develops medical-grade wearables and algorithms for health monitoring and diagnostics, to expand its suite of digital biomarkers for use in patient care and as digital endpoints in clinical trials.