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June 15, 2020

Portland medical device startup gets 'breakthrough' designation from FDA

The U.S. Food and Drug Administration has granted “Breakthrough Device” designation to a digital therapy being developed by Portland startup MedRhythms Inc.

MedRhythms’ medical device solutions use software, music and biosensors to help alleviate walking impairment in patients with neurologic disease or injury. The venture capital-backed company received the FDA designation for a solution treating stroke patients.

Breakthrough Devices are ones that meet specific FDA criteria for potentially offering more effective treatment or diagnosis of serious diseases or conditions, according to the federal agency’s website. Companies voluntarily apply for the designation, and if approved, receive close access to the FDA during product development and expedited regulatory review.

MedRhythms’ stroke product, the first in its pipeline, is also now being studied in a clinical trial at some of the nation's top rehabilitation hospitals and research centers. Stroke is a leading cause of disability in the United States. More than half of stroke survivors, roughly 3.5 million people across the country, have persistent walking deficits. 

"This digital therapeutic has the potential to address a significant unmet need in health care," MedRhythms CEO Brian Harris said in a news release.

"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."

In addition to stroke, MedRhythms said it continues to expand its pipeline with solutions under development for patients with Parkinson's disease and multiple sclerosis, and who are prone to falls.

Harris, a certified music therapist, co-founded the company in 2016 with Owen McCarthy, who studied biological engineering and serves as president. The pair were recognized on Mainebiz's 2018 Next List for their impact on Maine's economy. 

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