FDA OKs Empatica Health Monitoring Platform for Parkinson’s

Empatica, a digital biomarker and clinical-grande wearable tech company, has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance to market its health monitoring platform for Parkinson’s disease.

The clearance builds on Empatica’s 2025 acquisition of PKG Health, expanding its clinical-grade monitoring platform into Parkinson’s following its work in epilepsy and sleep. The platform combines PKG’s Parkinson’s measures with Empatica’s wearables to enable continuous symptom monitoring and generate objective data for clinical care and research.

The Empatica Health Monitoring Platform combines clinical-grade wearables, a patient app, cloud technology, and clinician portal to track Parkinson’s symptoms, including bradykinesia, dyskinesia, tremor, sleep, and medication compliance. Its algorithms have been studied in more than 70 peer-reviewed publications and used at over 150 hospitals and clinical sites worldwide.

The Boston, Mass.-based company said research using its PKG algorithms has shown that adding wearable data to patient demographics and clinical scores boosted the accuracy of predicting an optimal medication regimen by 33%, reaching 86.9%.

This marks the company’s twelfth FDA nod.

Comments from Empatica and clinicians

Matteo Lai, co-founder and CEO: “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 personalized care, and give researchers deeper insight into disease progression and treatment response.”

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: “Wearable monitoring enhances our understanding of how Parkinson’s symptoms change daily and respond to treatment. 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.”