Empatica Gets FDA Clearance for Parkinson's Monitoring Platform

Aug 19, 2026
Empatica received FDA 510(k) clearance for its Health Monitoring Platform for Parkinson's, which uses wearables, an app, cloud technology, and a clinician portal to track symptoms over time.

Empatica announced in a press release that its Empatica Health Monitoring Platform for Parkinson's has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The clearance expands Empatica's monitoring platform into Parkinson's after its 2025 acquisition of PKG Health.

The platform uses wearable devices, a patient app, secure cloud technology, and a clinician portal to monitor symptoms over time. It provides measures for bradykinesia, dyskinesia, tremor, sleep, medication compliance, and other aspects of Parkinson's management.

The algorithms have been studied in more than 70 publications reviewed by peers and used across more than 150 hospitals and clinical sites worldwide. Empatica said the clearance is its twelfth FDA clearance.

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