The US Food and Drug Administration (FDA) has given a breakthrough device designation for a patented digital therapeutic (MedRhythms, Portland, MN) to treat individuals with chronic walking impairment related to stroke. The effect of the device on chronic poststroke walking impairments is currently being studied in a 5-site randomized controlled trial (RCT) at the nation’s top rehabilitation hospitals and research centers.
"This digital therapeutic has the potential to address a significant unmet need in healthcare," said Brian Harris, chief executive officer and cofounder of MedRhythms. "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. The program will also provide diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Medical device developers must voluntarily request designation and demonstrate that their product meets applicable criteria in order to utilize the more flexible communication features of the program such as priority review, sprint discussions and clinical trial protocol agreement.
"I am pleased that our commitment to generating rigorous clinical evidence has allowed us to demonstrate our product's merit and to be recognized as a breakthrough device," said Danielle Briggeman, Clinical and Regulatory Affairs manager at MedRhythms. "Having this designation opens the door for swift, interactive discussions with FDA on our development efforts that we otherwise would not have under the current presubmission program. I am looking forward to our dialogue and hopeful that this will allow us to bring the product to market with an expedited timeline."
Zachary S. Gillis, BS, and Michael S. Cartwright, MD, MS
Peter McAllister, MD