Empatica Receives FDA Clearance for Parkinson's Monitoring

BOSTON, Aug. 19, 2026 /PRNewswire/ -- Empatica, a leader in digital biomarker development and clinical-grade wearable technology, today announced that the Empatica Health Monitoring Platform for Parkinson's has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The clearance builds on Empatica's 2025 acquisition of PKG Health and expands the company's clinical-grade monitoring platform into Parkinson's, following its established work in epilepsy and sleep. By bringing PKG's Parkinson's measures together with Empatica's wearables and connected technology, the platform enables continuous symptom monitoring and provides objective data to support more personalized care. The technology has been widely used by pharmaceutical companies, hospitals, and universities in Parkinson's research, including studies of disease progression, treatment response, and digital measures in clinical trials.

"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. This can help people better understand their symptoms, provide clinicians with data to support more personalized care, and give researchers deeper insight into disease progression and treatment response."

The Empatica Health Monitoring Platform uses clinical-grade wearables, a patient app, secure cloud technology, and a clinician portal to monitor symptoms over time. It provides validated measures of bradykinesia, dyskinesia, tremor, sleep, medication compliance, and other aspects of Parkinson's management. These algorithms have been studied in more than 70 peer-reviewed publications and used across more than 150 hospitals and clinical sites worldwide.

"Wearable monitoring enhances our understanding of how Parkinson's symptoms change daily and respond to treatment," said Ritesh Ramdhani, MD, Associate Professor of Neurology and Director of the Deep Brain Stimulation Program and Parkinson's and Movement Disorders Division at Northwell Health. "Bringing objective, real-world data into clinical care can assist clinicians in making more informed, personalized decisions and better support people living with Parkinson's."

Research led by Dr. Ramdhani has demonstrated the value of this approach in Parkinson's treatment planning. In one project using Empatica's PKG algorithms, adding wearable data to patient demographics and clinical scores improved the accuracy of predicting an optimal medication regimen by 33%, reaching 86.9% accuracy.

The clearance marks Empatica's twelfth FDA clearance, further strengthening its work in remote neurological monitoring, clinical research, and patient care.

About Empatica
Empatica Inc. is a leader in continuous remote health monitoring, using medical wearables and connected technology to turn real-world health data into meaningful insights. Its FDA-cleared products support clinical trials, research, and everyday care across a range of neurological and health conditions, including epilepsy and Parkinson's.

Madison Hamilton, Communications Director: [email protected]

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SOURCE Empatica, Inc.