With the US FDA approval, Rune Labs is enabled to expand the reach of its precision neurology platform for people at risk of developing Parkinson’s disease
StrivePD software will monitor PD suing Apple Watch. (Credit: fancycrave1 from Pixabay)
US-based precision neurology company Rune Labs has received the US Food and Drug Administration (FDA) 510(k) approval for its digital Parkinson’s Disease monitoring solution, StrivePD software ecosystem.
The regulatory approval allows the company’s StrivePD software ecosystem to collect patient data related to Parkinson’s Disease (PD) symptoms using an Apple Watch.
The monitoring solution combines advanced wearable technology and self-reported symptom information with brain imaging, electrophysiology, genetic and other clinical data.
StrivePD app enables a data-driven approach to care management and clinical trial design for PD patients, said Rune Labs.
It uses Apple’s Movement Disorder API, allowing independent researchers to collect patient data on the tremors and involuntary movements related to PD.
Rune Labs CEO and founder Brian Pepin said: “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.
“With all of the data we will collect and the patients we will reach through this clearance, we will make sure the right participants enrol 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.”
StrivePD app will also be available for patients who use Medtronic’s Percept PC Deep Brain Stimulation device, as part of an existing partnership between Rune Labs and Medtronic.
The US FDA approval will expand the reach of its precision neurology platform for people with or at risk of developing PD, said Rune Labs.
In addition, StrivePD on Apple Watch will help people with PD to easily track and log their symptoms, providing them enhanced control over their care.
The company leverages its Information Security Management System to protect the personal information and privacy of its users.
Rune Labs patient advisory board member Aura Oslapas said: “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.
“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.”