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.

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