Startup gets green light to use Apple Watch to track Parkinson’s symptoms

Software that enables Apple Watch-based tracking of Parkinson’s disease symptoms has received clearance from the Food and Drug Administration, a move that could open doors for its maker as it strives to reach more people living with movement disorders — and potentially, those who haven’t developed them yet.

The StrivePD system uses Apple’s Movement Disorder API to track tremors and dyskinetic symptoms of Parkinson’s from the Apple Watch. The data is all collected in an iPhone application, which allows patients to record their symptoms and keep tabs on medication.

StrivePD was developed by Rune Labs, a neurological data startup run by Brian Pepin, a former engineer from Alphabet life science company Verily. The company announced last year that it had raised nearly $23 million to continue to develop its neurology data platform. Also last year, the company launched a partnership with Medtronic to pilot data collection from the company’s Percept​​ PC Deep Brain Stimulation device. The StrivePD platform can integrate data from these devices, making it a kind of one-stop shop for clinicians and clinical trial sponsors who want to review data.

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The system has been used to monitor patients since last year at the University of California San Francisco and Mount Sinai, and the company is expanding its work further this year. The new FDA clearance specifically pertains to Rune’s Apple Watch-based symptom tracking capabilities and will make it possible for clinicians to use certain billing codes when reviewing data from the device. It will also allow trial sponsors to use the data as endpoints in studies submitted to regulators.

The company didn’t actually need regulatory clearance for how it displays the data to clinicians right now. But Pepin said it’s an important milestone for the company as it seeks to expand its work with pharma and med device companies. He also hopes the news will jumpstart an effort to identify people who have early signs of Parkinson’s.

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“I am really excited about the future prospect of being able to do something where we can leverage the very large installed population of the Watch to build the pipeline for prodromal patients to connect with trials in that space,” he said.

If Apple signed onto the effort, it could give a big boost to the push to passively monitor a large population in hopes of identifying the small number of people who might be eligible for a study. Pepin declined to say whether any collaborations were in the works. But Apple has long taken an interest in movement disorders and last year published research showing that the Apple Watch could accurately track symptoms of Parkinson’s — though it has said that it “doesn’t intend market movement disorder monitoring as a regulated medical device.”

The disease has become a battleground for big tech companies hoping to establish their credentials in health care: Verily has also spent years developing a Parkinson’s study watch and software tools to track the disorder’s symptoms.

Widely distributed devices like the Apple Watch that enable near-constant tracking of symptoms could help clinicians more closely monitor the disease’s progression and modify treatment between infrequent office visits.

There are several medical grade devices capable of tracking Parkinson’s symptoms, but using a device already familiar to consumers has many theoretical advantages. Millions of people already own Apple Watches, which could make it easier to recruit trial patients, including people who live in remote places or for whom travel is difficult. And because the device is popular and appeals to consumers, it’s more likely that someone using the tool to monitor symptoms long-term will stick with tracking consistently. The downside is that the Apple Watch and iPhone are relatively expensive devices inaccessible to many people. An Android version of StrivePD is not yet available.

Pepin said that as it becomes possible to track more validated metrics with the Apple Watch, it grows increasingly compelling for its capabilities as well as its wide distribution.

“We’ve invested in this infrastructure around the watch, and we’re able to pretty quickly — as the huge team at Apple that’s working on this stuff is able to spin out new features — take advantage of those,” he said. “And then, I think in some cases, we’ll be able to hopefully do more of what we did here, which is work with Apple to take it to the next step, which is this kind of formal FDA validation.”

Source: STAT