Wearable Platform Cleared for Parkinson Disease Symptom Monitoring
KEY TAKEAWAYS
- Empatica received FDA 510(k) clearance for its Health Monitoring Platform for Parkinson’s.
- The wearable platform provides longitudinal measures of bradykinesia, dyskinesia, tremor, sleep, medication compliance, and other Parkinson disease management parameters.
Empatica received FDA 510(k) clearance for the Empatica Health Monitoring Platform for Parkinson’s (Empatica, Cambridge, MA), a wearable-based system designed to support longitudinal monitoring of Parkinson disease (PD) symptoms.
The platform combines clinical-grade wearables, a patient-facing app, secure cloud infrastructure, and a clinician portal to track symptoms over time. According to a statement from Empatica, the system incorporates measures from PKG Health, which Empatica acquired in 2025, and is intended to provide objective data that may support treatment monitoring and individualized care decisions.
Platform Details
- The system provides measures of bradykinesia, dyskinesia, tremor, sleep, medication compliance, and other PD-related parameters.
- Empatica reported that the underlying algorithms have been evaluated in more than 70 peer-reviewed publications.
- According to the company, the technology has been used across more than 150 hospitals and clinical sites worldwide, including in PD research and clinical trial settings.
- Empatica said the clearance represents the company’s 12th FDA clearance.
The company also cited research using PKG algorithms in which adding wearable-derived data to patient demographics and clinical scores improved prediction of an optimal medication regimen by 33%, reaching 86.9% accuracy.
“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.”
Source
Empatica. Empatica receives FDA clearance for Parkinson’s monitoring. PR Newswire. Published August 19, 2026. Accessed August 19, 2026. https://www.prnewswire.com/news-releases/empatica-receives-fda-clearance-for-parkinsons-monitoring-302854529.html?utm_source=chatgpt.com