Empatica has secured FDA 510(k) clearance for its Health Monitoring Platform for Parkinson’s, extending its clinical‑grade remote monitoring capabilities into Parkinson’s care. The system continuously tracks bradykinesia, dyskinesia, tremor, sleep quality and medication adherence using wearables, a patient app, cloud services and a clinician portal. Its algorithms appear in 70+ peer‑reviewed studies and are used at 150+ sites; research showed a 33% improvement in predicting optimal medication regimens (86.9% accuracy). This marks Empatica’s 12th FDA clearance.
FDA Grants 510(k) Clearance to Empatica’s Parkinson’s Health Monitoring Platform
The technology has been used in Parkinson’s research
Empatica has received 510(k) clearance from the US Food and Drug Administration for its Health Monitoring Platform for Parkinson’s, enabling the company to expand its clinical‑grade remote monitoring tools into Parkinson’s care.
What the Platform Does
The system continuously measures core Parkinson’s symptoms — including bradykinesia, dyskinesia, tremor, sleep quality and medication adherence — by combining clinical‑grade wearable sensors, a patient mobile app, secure cloud infrastructure and a clinician portal. The platform delivers validated, objective measures designed to support disease management and therapeutic decision‑making.
Proven Algorithms and Clinical Use
Empatica’s underlying algorithms have been documented in more than 70 peer‑reviewed publications and are deployed at over 150 hospitals and clinical sites worldwide. The technology has been used in research on disease progression, treatment response and the development of digital outcome measures in clinical trials.
Research Evidence
A study led by the Northwell Health Deep Brain Stimulation Program and Dr Ritesh Ramdhani, Director of Parkinson’s and Movement Disorders and Associate Professor of Neurology, evaluated the combined approach. Dr Ramdhani reported that adding wearables‑derived data from Empatica’s PKG algorithms to standard clinical scores and patient demographic information increased accuracy in predicting an optimal medication regimen by 33%, achieving 86.9% accuracy.
Matteo Lai, CEO and Co‑Founder of Empatica: “This clearance marks an important step forward for Parkinson’s care. We are bringing objective, continuous monitoring into a platform designed for strong usability and scale. That can help people better understand their symptoms, support clinicians in delivering more personalised care and give researchers deeper insight into disease progression and treatment response.”
Company Milestones and Other Products
This is Empatica’s twelfth FDA clearance, broadening its portfolio across epilepsy, sleep and neurological health monitoring. In February 2024, Empatica launched EpiMonitor, an epilepsy monitoring system for adults and children aged six and above. The company’s digital health products are used both in research and in routine clinical care for a range of neurological and other health conditions.
Background: The 510(k) clearance follows Empatica’s 2025 acquisition of PKG Health, which supported integration of PKG’s Parkinson’s symptom measures with Empatica’s wearable and connected‑device technology.
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