Federal regulators have granted a special designation to a Portland company’s digital therapeutics program that is under development to fast-track the product’s rollout.
MedRhythms is building a direct simulation that uses sensors, music and software to lessen walking impairments brought on by stroke.
The company on Monday had its program designated a “breakthrough device” by the U.S. Food and Drug Administration. The designation means MedRhythms can speed up development, assessment and review of its product and interact with FDA experts to address topics as they arise during pre-market review and get prioritized submission review.
“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, MedRhythms’ clinical and regulatory affairs manager.
Stroke is a leading cause of disability, and more than half of stroke survivors, 3.5 million people, have long-term walking defects, the company said.
Send questions/comments to the editors.
Success. Please wait for the page to reload. If the page does not reload within 5 seconds, please refresh the page.
Enter your email and password to access comments.
Hi, to comment on stories you must . This profile is in addition to your subscription and website login.
Already have a commenting profile? .
Invalid username/password.
Please check your email to confirm and complete your registration.
Only subscribers are eligible to post comments. Please subscribe or login first for digital access. Here’s why.
Use the form below to reset your password. When you've submitted your account email, we will send an email with a reset code.