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Dive Brief:
H2o Therapeutics has received 510(k) clearance for an Apple Watch app that monitors Parkinson’s disease symptoms such as tremors and dyskinesia.
The smartwatch app uses Apple’s movement disorder API and the inertial sensors of the device to provide insights into patients’ symptoms between visits to their clinicians.
Apple validated the technology in a clinical trial, positioning h2o to create an app that enables the sharing of objective Parkinson’s symptom data between patients and medical professionals.
Dive Insight:
Apple laid the foundation for the app last year by publishing the results of a clinical trial of 343 people with Parkinson’s disease. The tech company ran the study to evaluate its Motor fluctuations Monitor for Parkinson’s Disease (MM4PD) system.
MM4PD uses inertial sensors in the smartwatch to continuously track fluctuations in resting tremor and dyskinesia, the uncontrolled, involuntary movements that affect people with Parkinson’s disease. Writing in Science Translational Medicine, researchers at Apple described how measurements from the app mapped to expert ratings of the presence of dyskinesia. The link to clinical evaluations of tremor severity was less robust, with a p value of 0.80, but the researchers concluded there was a correlation.
In 94% of cases, the smartwatch monitoring system captured symptom changes in response to treatment that matched clinicians’ expectations. Measurements from the other 6% of patients identified opportunities to improve the treatment strategy.
H2o, a Turkish, woman-founded company without venture capital funding, has used the validation of the movement disorder API to deliver its own app, Parky. The app provides clinicians with a daily chart of 288 data points captured each day, assuming the watch is worn continuously. Color is used to indicate patient status, with a greener screen indicating fewer symptoms.
The company has two more digital therapeutics products based on wearable devices in development, Foggy for neurodegenerative diseases, and Covie for COVID-19. It plans to complete submissions to the FDA next year.
