H2o Therapeutics’ Parky App for Monitoring Parkinson’s Disease Cleared
H2o therapeutics has gained 510(k) marketing clearance for its Apple watch-based prescription mobile app Parky for monitoring the symptoms of Parkinson’s disease.
The app uses the movement disorder application developed by Apple to monitor patients in daily life, tracking symptoms such as tremors and dyskinesia.
The Parky app, which helps clinicians develop a profile of the patient in daily life, “bridges the gap between real-life and in-clinic settings,” expanding the possibilities for data-driven treatment procedures, the company said.
H2o therapeutics is developing digital therapeutics with a focus on mobile technologies, augmented reality and artificial intelligence to gather real-time data for disease management.
The FDA said it is not changing its current recommendations for the recall, which is to seek a replacement device from the manufacturer.