Rune Labs’ StrivePD software has been granted FDA clearance to collect data for patients with Parkinson disease using the Apple Watch, supporting communication of data between clinicians and patients.
Rune Labs’ StrivePD software used for Parkinson disease (PD) has been granted 510(k) clearance by the FDA to collect patient data using the Apple Watch.
The company aims to enable a data-driven approach to care management and clinical trial design by combining wearable technology and self-reported symptom information with clinical data.
The StrivePD software collects data from Apple’s Movement Disorder API, which measures and records tremors and dyskinetic symptoms common in patients with PD.
The ability to track and log symptoms to StrivePD on the Apple Watch gives patients more control over their care, the company said. The FDA clearance will allow for patients with PD who already use these wearable devices to access care and participate in clinical trials through the StrivePD app.
“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," Aura Oslapas, who worked on the creation of the StrivePD mobile app and serves on Rune Labs’ Patient Advisory Board, said in a statement.
Rune Labs also intends to leverage the clearance to reach potential prodromal PD, who do not fit the diagnostic criteria for Parkin’s disease but exhibit symptoms.
Additionally, with Rune Labs’ and Medtronic’s existing partnership, the clearance will help clinicians interpret and utilize brain-sensing data from wearable devices for patients already using Medtronic’s Percept PC Deep Brain Stimulation device.
Rune Labs’ proprietary software platform integrates, analyzes, and displays data captured from the Medtronic device along with data from the StrivePD application, according to Neurology Live. The collaboration seeks to provide data to clinicians to support patient-specific treatment options, and the wearable device is another source of usable information.
“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," Oslapas said.
"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," she said.
Rune Labs hopes increased visibility into this data will not only improve the patient experience but also accelerate drug development and better inform trial designs.
"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," Brian Pepin, CEO and Founder of Rune Labs, said 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."
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