The clearance builds on Empatica’s 2025 acquisition of PKG Health and expands the company’s clinical-grade monitoring platform into Parkinson’s, following its established work in epilepsy and sleep. By bringing PKG’s Parkinson’s measures together with Empatica’s wearables and connected technology, the platform enables continuous symptom monitoring and provides objective data to support more personalized care. The technology has been widely used by pharmaceutical companies, hospitals, and universities in Parkinson’s research, including studies of disease progression, treatment response, and digital measures in clinical trials.

“This clearance marks an important step forward for Parkinson’s care,” said Matteo Lai, CEO and co-founder of Empatica. “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.”