Rune Labs, a precision neurology company, announced its StrivePD software ecosystem for Parkinson’s disease has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) to collect patient symptom data through measurements made by Apple Watch. By combining powerful wearable technology and self-reported symptom information with brain imaging, electrophysiology, genetic and other clinical data, StrivePD enables a data-driven approach to care management and clinical trial design for Parkinson’s.
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With this clearance, the Rune Labs’ StrivePD app enables precision clinical care and trial participation for tens of thousands of Parkinson’s patients who already use these devices in their daily lives. For patients who also use Medtronic’s Percept™ PC Deep Brain Stimulation device, this clearance for the StrivePD app will enhance clinicians’ ability to make brain-sensing data from these devices useful, as part of Rune Labs’ and Medtronic’s existing partnership. This clearance also sets the stage for leveraging StrivePD to reach a significant number of potential prodromal Parkinson’s patients.
Additionally, StrivePD on Apple Watch makes it easy for people with Parkinson’s to track and log their symptoms, enabling patients to have more control over their care.
“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 Parkinson’s to create the StrivePD mobile app. Since Rune Labs‘ acquisition of the StrivePD ecosystem 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 Parkinson’s 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.”