FDA Clears Wearable Parkinson Monitoring Platform

Empatica announced that the Empatica Health Monitoring Platform for Parkinson disease has received 510(k) clearance from the FDA. The platform combines PKG Health’s Parkinson measures with Empatica’s wearables and connected technology to enable continuous symptom monitoring and provide objective data that may support personalized care.

The system incorporates clinical-grade wearables, a patient application, secure cloud technology, and a clinician portal. It provides validated longitudinal measures of bradykinesia, dyskinesia, tremor, sleep, medication compliance, and other aspects of Parkinson management.

Wearable monitoring can help characterize how Parkinson symptoms change during daily life and respond to treatment. Ritesh Ramdhani, MD, of Northwell Health, said objective real-world data may help clinicians make more informed and personalized decisions.

Empatica reported that the platform’s Parkinson algorithms have been studied in more than 70 peer-reviewed publications and used at more than 150 hospitals and clinical sites worldwide. In one research project using the PKG algorithms, adding wearable data to patient demographics and clinical scores improved the accuracy of predicting an optimal medication regimen by 33%, reaching an accuracy of 86.9%.

The clearance follows Empatica’s acquisition of PKG Health in 2025 and represents the company’s 12th FDA clearance. The technology has also been used in Parkinson research examining disease progression, treatment response, and digital measures in clinical trials.

Source: Empatica, Inc. Empatica receives FDA clearance for Parkinson’s monitoring. News release. Empatica, Inc.; August 19, 2026. Accessed August 20, 2026.