H2o therapeutics has secured 510(k) marketing clearance from the US Food and Drug Administration (FDA) for Parky, its prescription-based mobile app for monitoring Parkinson’s Disease.
According to the Turkish digital health start-up, the Parky app uses the Apple Watch to continuously track symptoms like tremors and dyskinesia of the disease in real-time.
H2o therapeutics said that the app shares meaningful and reliable data on the progression of Parkinson’s Disease between patients and medical professionals for optimised treatment plans.
The app is said to fill the gap between real-world and clinical environments and increases the possibility of data-driven, customised treatment processes.
It also helps medical professionals build a clinical profile of the patient outside the clinic, the digital health firm said.
H2o therapeutics founder Yagmur Selin Gulmus said: “As a woman-founded, non VC-backed company based in Turkey, receiving our first 510(k) clearance is a huge milestone for us.
“We believe Parky will bring great value to the Parkinson’s Disease community as an easily scalable and data-driven product.”
The Parky app makes use of Movement Disorder API, a tool built by Apple. The tool’s validation was done in a study of 343 participants, which also included longitudinal tracking of 225 people for up to six months.
The company is developing two additional wearable-based digital therapeutics products, whose FDA submissions are expected to be finished next year.
H2o therapeutics develops mobile technologies-based digital therapeutics using augmented reality (AR), and artificial intelligence (AI).
