H2o Therapeutics announced recently that the FDA cleared its prescription mobile app, Parky, for monitoring Parkinson’s disease.
Ankara, Turkey–based H2o’s Parky app monitors symptoms including tremors and dyskinesia in real-time through the Apple Watch. In addition, the tool allows users and medical professionals to share meaningful and reliable data.
In a news release, the company said the app leverages the Apple-developed Movement Disorder API tool. As a result, the app helps medical professionals develop a clinical profile of the patient outside of the clinic.
H2o said its app strengthens the possibility of data-driven, tailored treatment procedures. The company noted that Parky bridges the gap between real-life and in-clinic settings.
“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,” said Yagmur Selin Gulmus, founder of H2o Therapeutics.
H2o said it currently has two more digital therapeutics products in its pipeline. The company expects to complete FDA submissions for those products — also based on wearable devices — in 2023. H2o’s technology uses augmented reality (AR) and artificial intelligence (AI). The company aims to transform real-time human data into a handy tool for disease management in certain therapeutic areas.