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.
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Empatica’s platform enables continuous tracking of symptoms such as bradykinesia, dyskinesia, tremor, sleep quality, and medication compliance.
The system combines clinical-grade wearable devices, a patient app, secure cloud features, and a clinician portal, providing validated measures to support disease management.
These algorithms have been featured in over 70 peer-reviewed publications and are used at more than 150 hospitals and clinical sites worldwide.
The technology has been deployed in Parkinson’s research, including studies of disease progression, treatment response, and digital outcome measures in clinical trial settings.
A research project was led by Northwell Health Deep Brain Stimulation Program and Parkinson’s and movement disorders division director and neurology associate professor Dr Ritesh Ramdhani on this approach.
Dr Ramdhani reported that supplementing clinical scores and patient demographic information with wearables-based data from Empatica’s PKG algorithms increased accuracy in predicting an optimal medication regimen by 33%, achieving 86.9% accuracy.
Empatica CEO and co-founder Matteo Lai said: “This clearance marks an important step forward for Parkinson’s care. We are bringing objective monitoring into a platform designed for great user experience and scale.
“This can help people better understand their symptoms, provide clinicians with data to support more personalised care, and give researchers deeper insight into disease progression and treatment response.”
The latest development represents 12th FDA clearance for Empatica, broadening its portfolio in fields including epilepsy, sleep, and neurological health monitoring.
The company’s digital health products are used in both research and routine care across a range of neurological and health conditions.
In February 2024, Empatica launched EpiMonitor, an epilepsy monitoring system for adults and children aged six and above.
