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

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

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

“As we have seen in oncology, the introduction of large amounts of real-world information has the potential to transform drug development and fundamentally alter disease prognosis.

“All the data we collect and the patients we reach through this clearance will ensure that the right participants are enrolled in the trials, and will help our pharma and Medtech partners run more efficient trials with high quality results data that will make them more efficient.” Rapid therapy will come on the market to help people with Parkinson’s. “

Why it matters

According to According to the National Institute of Neurological Disorders and Stroke, about 500,000 Americans have been diagnosed with Parkinson’s disease, although fewer diagnoses and misdiagnosis mean the actual number may be much higher. It is the second most common neurodegenerative disorder in the United States after Alzheimer’s disease.

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

“When people with Parkinson’s are given new drugs, adjusting how much to take and when to take it can be a long process,” said Aura Oslapas, creator of the StrivePD app and a member of the company’s Patient Advisory Board. , Said in a statement.

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

Greater trend

In September, Rune Labs announced that it was Series A raised $ 22.8 million in funding, producing $ 5 million seeds by 2020. The startup has recently expanded to Europe, adding a team of Portugal-based designers.

Meanwhile, Apple is expanding its health features on its watches. At the beginning of this month, tech giant Dr. WatchOS 9 has announced a number of new features, including a history of atrial fibrillation, which allows diagnosed users to track when their heart rate shows signs of AFib and what other factors may contribute, including sleep, alcohol use, and exercise. The feature has recently been cleared by the FDA.

Other digital health organizations that focus on neurodegenerative diseases include MindMaze, which Raised $ 105 million earlier this year for rehabilitation and assessment tools such as games; MedRhythms, which recently partnered with Biogen to develop and commercialize a therapeutic to improve mobility in people with multiple sclerosis; And Neuroglee, which raised $ 10 million last year for digital therapies aimed at slowing or improving cognitive impairment.

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