FDA Gives Nod to Parkinson’s Monitoring Apple Watch App From h2o Therapeutics

Turkish, all-female-founded digital health startup h2o Therapeutics has scored 510(k) clearance for its Apple Watch-paired application for monitoring common Parkinson’s disease symptoms such as dyskinesia and tremors. The app, aptly dubbed Parky, can provide clinicians with as many as 288 data points daily if the watch is worn continuously. Operating off the power of Apple’s movement disorder API as well as the watch’s inertial sensors, the app is meant to be a fill-in for the time between in-person check-ups to help gauge progression of the disease.

Apple’s successful 2021 clinical trial for its Motor fluctuations Monitor for Parkinson’s Disease (MM4PD) system acted as groundwork for apps like Parky to capitalize on the technology. In the trial, 94% of patients had their symptom fluctuations in response to treatment captured in a way that was accurate and useful to clinicians. The other 6% had their measurements marked for opportunities in firming up effective treatment strategies.

This hopefully won’t be h2o’s only FDA green light, as the up-and-coming company, which heretofore has achieved quite a bit without the benefit of any VC funding, has two other wearable devices in its pipeline. It is currently honing an app it calls “Covie” for COVID-19 and a digital therapeutic called “Foggy” for other neurodegenerative diseases, and plans to wrap up its FDA submissions for them next year.