H2o Therapeutics has been granted FDA approval for its Apple watch-based app designed to monitor symptoms of Parkinson’s disease.
Digital health start-up H2o Therapeutics has received marketing clearance from the US Food and Drug Administration (FDA) for its prescription mobile app for monitoring Parkinson’s disease.
Parky App monitors symptoms such as tremors and dyskinesia in real-time via the use of the Apple Watch.
The app leverages the Movement Disorder API, a tool developed by Apple and can be used for sharing meaningful and reliable data between patients and medical professionals regarding the course of the disease.
The API was validated in a study of 343 participants, including longitudinal tracking of 225 participants for up to six months and used the clinical gold standard (MDS-UPDRS) as a reference.
Parkinson’s disease is the fastest-growing neurological disorder, affecting 10 million patients worldwide.
Healthcare professionals in this area need reliable feedback and data for optimised treatment plans.
Parky App helps medical professionals to develop a clinical profile of the patient while outside of the clinic. The Parky App strengthens the possibility of data-driven, tailored treatment procedures and bridges the gap between real-life and in-clinic settings.
Yagmur Selin Gulmus, the founder of H2o Therapeutics, said in a statement: “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.”
H2o Therapeutics is developing digital therapeutics with a focus on mobile technologies, Augmented Reality (AR), and Artificial Intelligence (AI). It intends to utilise real-time human data as a tool for disease management in certain therapeutic areas.
The company has two more digital therapeutics products in the pipeline based on wearable devices and FDA submissions are planned to be completed in 2023.
