Apple Watch Parkinson’s monitoring app gets FDA approval


Apple Watch Parkinson’s monitoring was one of the things Apple demonstrated when it first announced ResearchKit, back in 2015. But a new developer partner has now taken this idea to a whole new level.

Rather than just gather aggregated data to help researchers, a new app can gather personalized data to provide doctors with much more reliable data for individual treatment …

What is Parkinson’s disease?

Here’s how the American Parkinson Disease Association describes it:

Parkinson’s disease (PD) is a type of movement disorder that can affect the ability to perform common, daily activities. It is a chronic and progressive disease, meaning that the symptoms become worse over time. It is characterized by its most common of motor symptoms—tremors (a form of rhythmic shaking), stiffness or rigidity of the muscles, and slowness of movement (called bradykinesia)—but also manifests in non-motor symptoms including sleep problems, constipation, anxiety, depression, and fatigue, among others.

There are an estimated 1 million people in the U.S. living with Parkinson’s disease and more than 10 million people worldwide. Most people who develop the symptoms of Parkinson’s disease do so sometime after the age of 50, but Parkinson’s disease can affect younger persons as well.

ResearchKit monitoring

The original Parkinson’s app offered specific tests, where the app would monitor movement during set sequences of movements, like walking 20 steps in each of two directions.

One view showed how the iPhone measures variation in your gait (the way that you walk) to help you walk. These consist of simple ‘structured tests’ that use the iPhone’s sensor and some input by the user to collect information about the person, helping their health and wider scientific knowledge.

With enough people trying the tests, this offered an opportunity to collect valuable statistical data for researchers.

In 2018, Apple added a new Movement Disorder API to ResearchKit, to allow continuous monitoring.

The new API will provide app developers using ResearchKit the ability to offer passive, all-day monitoring via an Apple Watch running watchOS 5. To achieve this the API will monitor two very common symptoms of Parkinson’s including Tremors, indicated by shaking and quivering detected by the Apple Watch, and Dyskinesia, a side-effect of treatments for Parkinson’s that causes fidgeting and swaying motions in patients.

However, this was still geared toward collecting aggregated data to assist researchers.

Clinical use of Apple Watch Parkinson’s monitoring

What’s new today is that a developer has been given US Food and Drug Administration (FDA) clearance to use a Parkinson’s monitoring app to gather individual data to assist their doctors to gather a more reliable assessment of a patient’s symptoms – and to use that data to provide better treatment plan. Reuters reports:

San Francisco-based startup Rune Labs on Monday said it has received clearance from the U.S. Food and Drug Administration to use the Apple Watch to monitor tremors and other common symptoms in patients with Parkinson’s disease.

The Rune Labs software uses the motion sensors built into the Apple Watch, which can already be used to detect when a person falls. Rune Labs Chief Executive Brian Pepin told Reuters in an interview the Apple Watch data will be combined with data from other sources, including a Medtronic (MDT.N) implant that can measure brain signals.

Rune Labs’ goal is for doctors to use the combined data to decide whether and how to fine-tune the patients’ treatment, an approach called precision medicine. At present, Pepin said, most doctors have to gather data on a patient’s movements by observing the patient during a short clinical visit, which is not ideal because Parkinson’s symptoms can vary widely over time.

The Apple Watch will give doctors a continuous stream of observations over long stretches, Pepin said.

A previous version of this piece referred to FDA ‘approval’ rather than ‘clearance.’ The FDA uses the latter term for devices which are of low risk, either because they are substantially similar to other products, or because a risk-assessment determines that they belong to the low-risk product classes.

Photo: Jesse Orrico/Unsplash

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