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Apple Watch gets FDA clearance to track Parkinson’s symptoms

Monday June 13, 2022. 06:02 PM , from Mac Daily News
In February 2021, Matthew Gavidia reported for the American Journal of Managed Care (AJMC) that an Apple Watch app designed to remotely monitor fluctuations of resting tremor and dyskinesia in persons with Parkinson disease was shown to match in-clinic evaluations of these symptoms and capture symptom changes in response to treatment for 94% of participants. Now, 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 StrivePD app uses Apple Watch to track Parkinson’s symptoms
Rune Labs, a precision neurology company, today 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.
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, in a statement. 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.”
“As we have seen in oncology, the introduction of large quantities of real-world data has the power to transform drug development and fundamentally change disease prognosis. This clearance is a major step towards building a similar paradigm in neurology,” said Brian Pepin, CEO and Founder of Rune Labs, in a statement. “With all of the data we will collect and the patients we will reach through this clearance, we will make sure the right participants enroll in trials, and help our pharma and medtech partners run more efficient trials with higher quality outcomes data, thereby enabling more therapies to come to market quickly to help those suffering from Parkinson’s.”
Until now, clinicians and researchers have made decisions surrounding patient care based on limited information and data. Rune Labs is bringing together novel multimodal data that will radically transform what it means to be a patient with Parkinson’s. 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 StrivePD ecosystem draws data directly from Apple’s Movement Disorder API, which provides a power-efficient approach to measuring and recording tremors and dyskinetic symptoms common in patients with Parkinson’s disease. Rune Labs values users’ personal information and privacy and takes appropriate steps to protect against unauthorized access, alteration, disclosure, misuse, or destruction. Users’ personal information and privacy is protected and governed by Rune Labs’ Information Security Management System.
MacDailyNews Note: More info about Rune Labs here. More info about the StrivePD app via Apple’s App Store here.
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The post Apple Watch gets FDA clearance to track Parkinson’s symptoms appeared first on MacDailyNews.
https://macdailynews.com/2022/06/13/apple-watch-gets-fda-clearance-to-track-parkinsons-symptoms/

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