BOSTON — Empatica said its Health Monitoring Platform for Parkinson’s has received 510(k) clearance from the U.S. Food and Drug Administration, expanding the company’s clinical-grade wearable monitoring technology into Parkinson’s disease.
The clearance follows Empatica’s 2025 acquisition of PKG Health and builds on the company’s existing work in epilepsy and sleep monitoring.
The platform combines PKG’s Parkinson’s measures with Empatica’s wearable devices, patient app, secure cloud technology and clinician portal to provide continuous symptom monitoring and objective data intended to support more personalized care.
“This clearance marks an important step forward for Parkinson’s care,” said Matteo Lai, CEO and Co-Founder of Empatica. “We are bringing objective monitoring into a platform designed for great user experience and scale.”
The platform provides validated measures of bradykinesia, dyskinesia, tremor, sleep, medication compliance and other aspects of Parkinson’s management.
Empatica said the underlying algorithms have been evaluated in more than 70 peer-reviewed publications and used across more than 150 hospitals and clinical sites worldwide.
The technology has also been used by pharmaceutical companies, hospitals and universities in Parkinson’s research, including studies of disease progression, treatment response and digital measures in clinical trials.
“Wearable monitoring enhances our understanding of how Parkinson’s symptoms change daily and respond to treatment,” said Ritesh Ramdhani, M.D., Associate Professor of Neurology and Director of the Deep Brain Stimulation Program and Parkinson’s and Movement Disorders Division at Northwell Health.
Ramdhani said incorporating objective, real-world data into clinical care can help clinicians make more informed and personalized treatment decisions.
Empatica also cited research led by Ramdhani in which the addition of wearable data to patient demographics and clinical scores improved the accuracy of predicting an optimal medication regimen by 33%, reaching 86.9% accuracy.
The company said the FDA action represents its 12th clearance and further expands its work in remote neurological monitoring, clinical research and patient care.
