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Apple Watch-based Rune Labs Parkinson’s disease tracking device gets FDA approval

Software that helps people with Parkinson’s disease track their symptoms with their Apple Watch has been approved by the Food and Drug Administration, the company behind the tool said today. It automatically tracks things like tremor and allows patients to report symptoms and medication use.

Neurology company Rune Labs has built software called StrivePD. It allows clinicians to track the progress of their patients and any changes in the symptoms of the neurological disorder that causes involuntary movements and difficulty coordinating. Passive data collection means that patients should not try to remember these fluctuations. It is also a rich source of data on how patients with Parkinson’s disease respond to various drugs.

“With all the data we collect and the patients we reach through this permission, we will make sure the right participants are enrolled in the studies,” said Brian Pepin, CEO and founder of Rune Labs. This will make trials more effective and bring drugs to market faster, he said.

Patients have been using the app for about a year, but FDA approval means clinicians have ways to charge patients when they view watch data, and allow the findings to be used as data from clinical trials for various treatments for Parkinson’s disease, Stat News reported.

StrivePD uses the Apple Movement Disorder API, which Apple launched for the first time in 2018, to allow independent researchers to download information about tremors and involuntary movements associated with Parkinson’s disease. Other companies are also using the Disorders API to provide Parkinson’s patients with similar information.

Apple is not officially involved in the Rune Labs project, but Apple did its own study of the Apple Watch and Parkinson’s disease. In 2021, Apple researchers published data showing that the watch can accurately track changes in motor symptoms in patients with Parkinson’s disease.