MedRhythms this week said it received FDA breakthrough device designation for its digital therapeutic device that treats chronic stroke walking deficits.
The company uses sensors, music and software to create evidence-based, neurologic interventions to measure and improve walking. The device is currently being studied in a randomized controlled trial to evaluate the impact of the device on chronic stroke walking impairments.
“This digital therapeutic has the potential to address a significant unmet need in healthcare,” CEO and co-founder Brian Harris said in a news release. “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.”
MedRhythms also said it is expanding its product pipeline for people who suffer from the effects of other neurologic injuries and diseases, including Parkinson’s disease, multiple sclerosis, aging and fall prevention.
“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 Pre-Submission 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.”