mHealth Platforms for Chronic Care Get the Green Light From the FDA

Federal regulators have signaled their support for a pair of mHealth platforms that use digital therapeutic tools to improve chronic care management.

The US Food and Drug Administration has granted clearance to EndeavorRx, a connected health treatment that uses video game technology to approve attention function in children with attention deficit/hyperactivity disorder (ADHD). The platform, to be made available by prescription, was developed by Boston-based Akili Interactive.

“With EndeavorRx, we’re using technology to help treat a condition in an entirely new way as we directly target neurological function through medicine that feels like entertainment,” Eddie Martucci, PhD, the company’s chief executive officer, said in a press release. “Families are looking for new ways to help their children with ADHD. With today’s decision by FDA, we’re excited to offer families a first-of-its-kind non-drug treatment option and take an important first step toward our goal to help all people living with cognitive issues.” 

The FDA’s clearance was based on data from five clinical studies, involving more than 600 children, one of which was profiled in The Lancet Digital Health Journal. In that study, conducted by researchers at Duke University, after a month of EndeavorRx treatment, one-third of the participants no longer had a measurable attention deficit on at least one measure of objective attention and roughly half of parents saw a clinically meaningful change in their child’s day-to-day impairments. That percentage of parents increased to 68 percent after a second month of treatment.

"For children living with ADHD, improving their ability to focus and resist distraction is critical to their daily functioning and performance in school,” Elysa Marco, MD, a cognitive and behavioral child neurologist and clinical executive for Neurodevelopmental Medicine at Cortica Healthcare, said in the press release.

Separately, the FDA has granted Breakthrough Device Designation to a digital therapeutic platform developed by MedRhythms that combines mHealth sensors, AI software and guided music therapy to help stroke survivors with walking impairments.

"This digital therapeutic has the potential to address a significant unmet need in healthcare," Brian Harris, CEO and co-founder of the Portland, ME-based company, said in a press release. "There is currently no standard of care for chronic stroke survivors with walking deficits, yet these impairments are strongly linked to fall risk, lack of independence, and decreased quality of life. We are thrilled the FDA has designated our product as a Breakthrough Device, recognizing its potential to impact an area of high unmet need and bringing us one step closer to reaching people who need this care."

The platform, which pairs software with music to guide patients in walking exercises, is currently being tested at five rehabilitation hospitals across the country: New York-based Mount Sinai Health System, the Shirley Ryan AbilityLab in Chicago, the Kessler Foundation in New Jersey and Spaulding Rehabilitation Hospital and the Boston University Neuromotor Recovery Laboratory, both in Boston.

MedRhythms began as a digital therapy program launched out of Spaulding Rehab, part of the Partners HealthCare network, and has been building a portfolio of digital therapeutic treatments for treatment of neurological injury and disease, including Parkinson’s Disease and Multiple Sclerosis. The company is also looking to apply the treatment to senior care and fall prevention programs.