The Apple Watch Has Been Cleared by the FDA to Monitor Parkinson’s Disease Symptoms

Approximately 60,000 new cases are diagnosed yearly.
Apple Watch Health Monitoring Features Credit: ms_pics_and_more / Shutterstock
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It’s been four years in the making, but the Apple Watch has finally gotten the green light to monitor for symptoms of Parkinson’s disease.

Apple hinted at studying Parkinson’s disease as one possibility when it announced its ResearchKit initiative in 2015. However, it wasn’t until 2018 that Apple added an API that researchers could take advantage of. The Movement Disorder API offered a way for the Apple Watch to monitor for typical Parkinson’s disease symptoms like tremors and dyskinesia.

Now, four years after those studies first began to take shape, the U.S. Food and Drug Administration (FDA) has cleared the first watchOS app to monitor the symptoms common in patients with Parkinson’s disease.

According to Reuters, San Francisco-based startup Rune Labs has developed an app that will use the same motion sensors that power Apple’s Fall Detection feature to help provide patients with better care and treatment.

However, the Apple Watch will only be one part of a multi-pronged approach. Rune Labs Chief Executive Brian Pepin told Reuters that data from the Apple Watch will be combined with data from other sources, including a Medtronic implant that will measure brain signals.

The app’s objective isn’t necessarily to detect the onset of Parkinson’s disease but to help treat those living with the condition by giving doctors as much data as possible to work with.

When you think about the process of getting someone to their optimal therapy or combination of drugs or devices, or even whether or not a patient might be a good fit for certain clinical trial, it’s a very hard decision to make when you only have a little context.

Brian Pepin, CEO, Rune Labs

As with many medical conditions, doctors typically only have an opportunity to detect symptoms and conditions when a person comes into their office. This is precisely why atrial fibrillation (Afib) often flies under the radar — and why the Apple Watch has made an enormous difference in the lives of people experiencing infrequent abnormal heart rhythms.

The same problem hampers Parkinson’s disease treatment. As Pepin explains, Parkinson’s symptoms can vary widely over time, so it’s challenging for doctors to understand the bigger picture of a patient’s movements during a short clinical visit. The Apple Watch will fill this significant gap by offering “a continuous stream of observations over long stretches,” Pepin added.

This FDA clearance marks the first high-profile use of Apple’s Movement Disorder API. Rune Labs began exploring the idea last year after a group of scientists at Apple published a study in the journal Science Translation Medicine demonstrating how the Apple Watch could help monitor Parkinson’s symptoms.

After ready the study, Pepin contacted Apple about the tools and methods involved, adding that it “took about eight minutes” for Apple’s research team lead to get back to him and open discussions toward exploring how the Movement Disorder API could be put to practical use for treating patients with Parkinson’s disease in the field.

The Michael J. Fox Foundation for Parkinson’s Research estimates that Parkinson’s affects nearly one million people in the United States and more than 6 million worldwide. In late 2019, Apple filed a patent for passive tracking of dyskinesia and tremor symptoms, citing these same statistics and adding that approximately 60,000 new cases are diagnosed yearly.

Parkinson’s is particularly challenging to treat as each person’s symptoms and progression are unique. This makes the kind of precise monitoring possible with an Apple Watch all the more important in helping medical professionals determine specialized treatment for each person.

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