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