FDA Approves Parkinson's Monitoring System On Apple Watch

A San Francisco-based company has received the U.S. Food and Drug Administration (FDA) nod for software that tracks Parkinson's symptoms using the Apple Watch, according to a press release (via PRNewswire). Called StrivePD, the health software combines information gathered from "brain imaging, electrophysiology, genetic and other clinical data," the company explains. With the software running on an Apple Watch, folks with Parkinson's disease will be able to keep a tab on symptoms and track relevant medical events.

The latter is crucial because a detailed breakdown of motor activity fluctuation will allow medical experts to arrive at the best medication schedule and dosage level more quickly. Moreover, the multimodal data and neurological metrics collected during the trials will also help speed up drug research and development. Rune Labs, the company behind the breakthrough, will rely on Apple's Monitoring Movement Disorder API to further develop the software ecosystem around StrivePD.

Apple's API is used to record dyskinetic symptoms and tremors — an involuntary rhythmic shaking or body movement — that serve as one of the core signs of Parkinson's during diagnosis and subsequent treatment. At the moment, the MDS-UPDRS assessment is regarded as the most reliable observation method by neurologists. However, the conclusions might vary from one expert to another, and there is also a realistic chance that the symptoms might appear subdued during the 30-minute assessment session. Bringing a commercially available device like the Apple Watch into the fold has multiple benefits.

Once the StrivePD software is deployed on the Apple Watch, it will rely on passive data collection over a longer period of time. For users, this means they won't have to manually log every event. For neurologists, the wearable software will offer a much more detailed dataset to analyze the history of tremors and dyskinetic movement abnormalities. And since the Apple Watch is available globally, Rune Labs' solution can be distributed to users all across the world (pending local approval), unburdening them from pricey medical-grade equipment.

In a research paper that was published in Science Translational Medicine (via Science), it was revealed that the Apple Watch can detect tremors that produce a body displacement as small as 0.1 cm. Tremors of such a small scale might even go unnoticed by specialists. During the clinical study that involved 343 participants, the Motor fluctuations Monitor for Parkinson's Disease (MM4PD) system was able to recognize symptoms that matched analysis done by clinical experts in 94% of the cases.

According to the Parkinson's Foundation, more than 10 million people across the world are currently living with Parkinson's Disease, of which, nearly 1 million live in the United States. It is estimated that the number of people living with Parkinson's Disease in the U.S. will reach the 1.2-million mark by the year 2030. Rune Labs hasn't set a timeline regarding the wide rollout of its software solution for the Apple Watch, but it is definitely a step in the right direction.