MedRhythms, a digital therapeutics and medical-device startup in Portland, announced on Monday that it had received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its patented digital therapeutic device that helps patients suffering from stroke-induced walking deficits to regain mobility.

Stroke is a leading cause of disability in the United States. More than half of stroke survivors, approximately 3.5 million people in the US, have persistent walking deficits. These long-term functional deficits negatively impact the lives of stroke survivors and their caregivers. This population is expected to grow with an increasing stroke survival rate and the aging population in the United States.

The impact on chronic stroke walking impairments of the company’s product, which is the first in its pipeline of digital therapeutics for neurologic disease and injury, is currently being studied in a randomized controlled trial at some of the nation’s top rehabilitation hospitals and research centers.

“This digital therapeutic has the potential to address a significant unmet need in healthcare,” Brian Harris, CEO and co-founder of MedRhythms, said in a statement. “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 FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

The company, which recently raised money from Bose Ventures, has several other products in its pipeline to address the negative effects of other neurologic injuries and diseases, including Parkinson’s disease, multiple sclerosis, aging, and fall prevention.