Empatica has received the US Food and Drug Administration (FDA) 510(k) clearance for its Health Monitoring Platform for Parkinson’s, enabling the company to extend its clinical-grade remote monitoring technology into disease care.

The clearance follows 2025 acquisition of PKG Health, which supported the integration of its Parkinson’s symptom measures with the wearable devices and connected technology of Empatica.

Empatica’s platform enables continuous tracking of symptoms such as bradykinesia, dyskinesia, tremor, sleep quality, and medication compliance.