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 gather patient symptom data through quantifications made by Apple Watch. By combining influential 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.
With this approval, the Rune Labs’ StrivePD app allows 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 utilize brain-sensing data from these devices to its fullest potential, 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, empowering patients to have more control over their care.
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