h2o Therapeutics Receives European MDR Certification for Its Apple Watch-Based App for Parkinson's Disease

ANKARA, TR / ACCESS Newswire / May 30, 2025 / h2o Therapeutics announced that it has received European Union Medical Device Regulation (EU MDR) Class IIa certification for Parky, a mobile app designed to monitor and manage Parkinson's Disease (PD) symptoms via Apple Watch. This follows the 510(k) clearance previously granted by the U.S. Food and Drug Administration (FDA) in 2022, making Parky one of the few internationally regulated mobile medical apps specifically developed for Parkinson's.

Parky utilizes Apple's Movement Disorder API to track motor symptoms such as tremors and dyskinesia in real time. The data is securely shared with healthcare professionals, allowing for continuous remote symptom tracking and personalized treatment adjustments. The underlying API was validated in a 343-participant study - 225 of whom were monitored for up to six months - referencing the gold-standard MDS-UPDRS clinical scale. The findings were published in Science Translational Medicine.

With EU MDR Class IIa certification, Parky is now eligible for clinical use in over 30 countries that recognize the EU MDR regulatory framework, including all EU member states and multiple non-EU jurisdictions that adopt or align with these standards. "Receiving EU MDR certification is another transformative milestone for us," said Yagmur Selin Gulmus, founder of h2o Therapeutics. "This recognition confirms our ability to meet the highest global standards in digital health. We're now actively seeking strategic partnerships to support Parky's global adoption and bring its benefits to Parkinson's communities worldwide."

Parkinson's Disease, affecting more than 10 million people globally, is the fastest-growing neurological disorder. Parky bridges the gap between episodic clinical assessments and real-world patient experience, enabling data-driven, individualized care through continuous passive monitoring.

h2o Therapeutics is a digital health company developing clinically validated, wearable-integrated software solutions for neurological and chronic conditions. Based in Türkiye, the company combines rigorous regulatory pathways with consumer-first design to create prescription digital therapeutics (PDTs) that improve patient outcomes and support continuous, real-world care.

SOURCE: h2o therapeutics