By: IPP Bureau
Last updated : August 21, 2026 5:54 pm
The platform is designed to provide continuous, objective monitoring of Parkinson’s symptoms and treatment response, including bradykinesia, dyskinesia, tremor, sleep, motor fluctuations, gait and medication compliance
Empatica, a digital health company based out of Cambridge, Massachusetts, has received US Food and Drug Administration (FDA) 510(k) clearance for its Health Monitoring Platform for Parkinson’s Disease Monitoring, expanding its clinical-grade remote monitoring technology into routine Parkinson’s care.
The FDA records show the clearance was granted on August 14, 2026, under 510(k) number K260374.
The development follows Empatica’s acquisition of PKG Health in October 2025, which brought PKG’s validated movement-disorder algorithms together with Empatica’s wearable devices, software and connected health infrastructure.
The platform is designed to provide continuous, objective monitoring of Parkinson’s symptoms and treatment response, including bradykinesia, dyskinesia, tremor, sleep, motor fluctuations, gait and medication compliance.
It combines Empatica’s medical-grade wearable technology with a companion app, cloud-based data management and a clinician portal that provides access to patient data and PKG reports.
According to Empatica, the PKG algorithms can provide more than 30 validated movement-disorder measures and have been used in clinical research and care to assess symptoms, treatment response and disease progression.
Research led by Dr Ritesh Ramdhani, Associate Professor of Neurology and director of the Deep Brain Stimulation Program and Parkinson’s and Movement Disorders Division at Northwell Health, has examined the use of wearable-derived PKG data to support personalised Parkinson’s treatment.
Empatica says the approach improved prediction of an optimal medication regimen by 33%, reaching 86.9% accuracy, when wearable data were combined with clinical scores and patient demographic information.
“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,” said Matteo Lai, CEO and co-founder of Empatica.
The FDA clearance further broadens Empatica’s regulatory footprint in neurological health. The company previously received FDA clearance for its
EpiMonitor epilepsy monitoring system in February 2024, while its broader Health Monitoring Platform has also received earlier FDA clearances.
Empatica had secured CE MDR certification for its Parkinson’s monitoring offering in January 2026, enabling clinical use in Europe and the UK ahead of the US clearance.