Rune Labs Gets FDA Clearance to Use Apple Watch in Monitoring Parkinson's Disease Symptoms

Apple's smartwatches have just become one of the tools used to track symptoms of Parkinson's disease.

Precision neurology company Rune Labs announced it had secured a clearance from the Food and Drug Administration (FDA) to track symptoms of Parkinson's disease through measurements made by Apple Watch using the software ecosystem the company developed.

The FDA's clearance for Rune Labs is the first prominent use of software tools that Apple released for measuring movement disorders in 2018, per Reuters.

Rune Labs FDA Approval Details

Rube Labs mentioned in its announcement that the FDA granted it a 510(k) clearance to collect patient symptom data through measurements made by Apple Watch. To do so, the company will utilize its StrivePD app software ecosystem that will gather data through brain imaging, electrophysiology, genetic, and other clinical data, allowing the StrivePD app to track and log their symptoms.

The symptoms StrivePD looks for are usually tremors, involuntary or slow movement, rigidity, and poor balance, per Engadget.

The FDA clearance allows Rune Labs to enable precision clinical care and trial participation for tens of thousands of Parkinson's patients who already have and use Apple's smartwatches in their daily lives.

Patients of also use Medtronic's Percept PC Deep Brain Stimulation device can also benefit from Rune Labs' StrivePD as it enhances clinicians' ability to make brain-sensing data from these devices useful, thanks to the partnership between the two companies.

Rune Labs' StrivePD ecosystem is said to take data directly from Apple's Movement Disorder API to provide a power-efficient approach to measuring and recording tremors and dyskinetic symptoms common in patients with Parkinson's disease.

"Until now, clinicians and researchers havd made decisions surrounding patient care based on limited information and data," Rune Labs said in its announcement. "Having visibility into this data will accelerate drug development, using high resolution metrics to inform trial design, endpoint slection and patient stratification, as well as whether a treatment effect is detected."

Aura Oslapas, the creator of the StrivePD mobile app from her first-hand experience with Parkinson's, said that StrivePD not only helps track and records their symptoms and improvements but also accelerates the time to an optimal medication schedule.

Oslapas also called the app the "long-awaited union of quantitative and qualitative data that encourages better care and communication between patients and clinicians." She added that the app would also empower people with the disease to live better every day.

She also referred to the introduction of large quantities of real-world data in oncology, saying that should when the same thing happens in neurology, pharma and MedTech partners will be able to run more efficient trials with higher quality outcomes data, allowing more therapies to quickly come to market to help those suffering from Parkinson's.

Other Medically-Aligned Features Of Apple's Smartwatches

Aside from the Movement Disorder API, Apple's smartwatch also has AFib History, a feature that will be released in the upcoming watchOS 9 update that monitors irregular and extremely rapid heartbeat.

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