Home Medicine Rune Labs scores FDA 510(k) to monitor Parkinson’s symptoms on Apple Watch

Rune Labs scores FDA 510(k) to monitor Parkinson’s symptoms on Apple Watch

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Brain data startup Rune Labs announced Tuesday it received FDA 510(k) clearance to use its StrivePD app to monitor Parkinson’s disease patients’ symptoms through the Apple Watch.

The StrivePD system uses Apple’s Movement Disorder API to track tremors and dyskinesia, or uncontrolled, involuntary body movement. Patients can also use the app to log their medications, side effects and other symptoms. As part of a partnership with Medtronic announced last year, patients using the company’s deep brain stimulation device can share that information with care teams as well.

“As we have seen in oncology, the introduction of large quantities of real-world data has the power to transform drug development and fundamentally change disease prognosis. This clearance is a major step towards building a similar paradigm in neurology,” Rune Labs CEO and founder Brian Pepin said in a statement.

“With all of the data we will collect and the patients we will reach through this clearance, we will make sure the right participants enroll in trials, and help our pharma and medtech partners run more efficient trials with higher quality outcomes data, thereby enabling more therapies to come to market quickly to help those suffering from Parkinson’s.”

WHY IT MATTERS

According to the National Institute of Neurological Disorders and Stroke, around 500,000 Americans have been diagnosed with Parkinson’s disease, though underdiagnoses and misdiagnoses mean the actual count may be much higher. It’s the second most common neurodegenerative disorder in the U.S., after Alzheimer’s disease.

Rune Labs said the clearance could improve clinical trial design and allow for more data-driven care for Parkinson’s patients.

“When people with Parkinson’s are prescribed new medications, adjusting how much to take and when to take it until they find something that works can be a lengthy process,” Aura Oslapas, creator of the StrivePD app and a member of the company’s patient advisory board, said in a statement.

“StrivePD helps people to track their symptoms and improvements, accelerating the time to an optimal medication schedule – and with today’s clearance, more people will have access to this life-changing technology.” 

THE LARGER TREND

In September, Rune Labs announced it had scooped up $22.8 million in Series A funding, building off a $5 million seed from 2020. The startup recently expanded into Europe with the addition of a team of designers based in Portugal. 

Meanwhile, Apple has been expanding its health features on its Watch. Earlier this month, the tech giant announced a host of new features coming with watchOS 9, including atrial fibrillation history, which allows diagnosed users to track when their heart rhythm shows signs of AFib and what other factors may contribute, including sleep, alcohol use and exercise. The feature was recently cleared by the FDA.

Other digital health companies that are focused on neurodegenerative disease include MindMaze, which raised $105 million earlier this year for its game-like rehab and assessment tools; MedRhythms, which recently partnered with Biogen to develop and commercialize a therapeutic to improve mobility for people with multiple sclerosis; and Neuroglee, which raised $10 million last year for a digital therapeutic geared toward slowing or improving cognitive impairment.

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