MedRhythms has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its patented digital therapeutic to treat chronic stroke walking deficits, it announces.
This product is reportedly the first in the Portland, Maine-based digital therapeutics company’s pipeline of digital therapeutics for neurological disease and injury. A randomized controlled trial is being conducted to study the device’s impact on chronic stroke walking impairments.
“This digital therapeutic has the potential to address a significant unmet need in healthcare,” Brian Harris, CEO and co-founder of MedRhythms, says in a media 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.”
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 or 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, per the release.
“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,” states 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,” she adds.
[Source(s): MedRhythms, PR Newswire]