The system uses clinical-grade wearables and algorithms to provide objective data on tremors, sleep, and medication compliance.
Empatica has received 510(k) clearance from the Food and Drug Administration for its Parkinson’s health monitoring platform. The clearance builds on the company’s 2025 acquisition of PKG Health and expands its monitoring technology into Parkinson’s care, following previous work in epilepsy and sleep.
The platform combines wearable technology with a patient application, cloud systems, and a clinician portal to enable continuous symptom monitoring. It is designed to provide objective data for managing bradykinesia, dyskinesia, tremor, sleep, and medication compliance.
“This clearance marks an important step forward for Parkinson’s care,” says Matteo Lai, CEO and co-founder of Empatica, in a release. “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.”
Clinical Validation and Research Applications
The technology has been used by hospitals, universities, and pharmaceutical companies to study disease progression and treatment response in clinical trials. The underlying algorithms have been evaluated in more than 70 peer-reviewed publications and used at more than 150 clinical sites worldwide.
“Wearable monitoring enhances our understanding of how Parkinson’s symptoms change daily and respond to treatment,” says 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, in a release. “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 Ramdhani showed that adding wearable data to patient demographics and clinical scores improved the accuracy of predicting optimal medication regimens by 33%, reaching 86.9% accuracy.
This latest clearance is the 12th FDA clearance for Empatica, which focuses on remote neurological monitoring and clinical research.
Photo caption: Empatica Health Monitoring Platform for Parkinson’s
Photo credit: Empatica
