FDA Clears Parkinson Disease Monitoring Application

The Food and Drug Administration (FDA) gave 510(k)clearance to a monitoring application (StrivePD; Rune Labs, San Francisco, ) for Parkinson disease (PD) symptom tracking for use on the Apple Watch.

The application’s combination of movement tracking and self-reported symptoms information with clinical data including brain imaging, electrophysiology, and genetics potentially enables better management for medical care.

The clearance for the application provides precision clinical care as well as the ability to make use of brain-sensing data through an existing partnership between Rune Labs and Medtronic for people who use the Percept PC deep brain stimulation device.

The clearance also allows identification of individuals with presymptomatic PD. 

"Being able to show my neurologist how my motor symptoms were fluctuating, thanks to StrivePD, was the impetus for me to get surgery for a deep brain stimulation device," said Aura Oslapas, who drew from her first-hand experience with PD to create the StrivePD mobile app. Since Rune Labs' acquisition of StrivePD in 2019, Oslapas has worked with the company to evolve the StrivePD user experience, and also recently joined its Patient Advisory Board.

"When people with PD are prescribed new medications, adjusting how much to take and when to take it until they find something that works can be a lengthy process. StrivePD helps people to track their symptoms and improvements, accelerating the time to an optimal medication schedule – and with today's clearance, more people will have access to this life-changing technology," Oslapas said. "StrivePD on Apple Watch is the long-awaited union of quantitative and qualitative data that encourages better care and communication between patients and clinicians, while also empowering people with Parkinson's who are striving to live better every day."

The novel multimodal data from the application will aid clinicians and researchers to make data-driven decisions surrounding patient care, such as whether or not medication doses need to change or adjunctive treatments should be added.

Having visibility into this data will accelerate drug development, using higher resolution metrics to inform trial design, endpoint selection and patient stratification, as well as whether a treatment effect is detected.

The application use will accelerate drug development, using higher resolution metrics to inform trial design, endpoint selection, and patient stratification. Users personal information and privacy will be protected against unauthorized use. Apple's Movement Disorder API delivers data to the application with a power-efficient approach to measuring and recording tremors and dyskinetic symptoms.