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. Read more

Related Posts

UNE receives $10.8 million to establish new Center for Cell Signaling Research

The University of New England has received a five-year, $10.8 million award from the National Institutes of Health to support an...

18 January 2024

Jackson Lab opens $4.5M on-site child care center in Bar Harbor

Anewly constructed child care center on the Jackson Laboratory’s Bar Harbor campus is seen as an important draw for employees that also...

17 January 2024

From med tech to skin care: Top Gun names 41 startups to 2024 lineup

Out of 57 companies that applied to Maine’s 2024 Top Gun business accelerator program, 41 have been accepted and will receive help...

16 January 2024