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Rotation Medical gets 510(k) clearance for implantable collagen scaffold technology

Rotation Medical Inc. recently announced it has received 510(k) clearance for its implantable collagen scaffold technology.

Used to treat rotator cuff disease, the new technology is designed for use during arthroscopic and mini-open procedures to help support clinical management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

“Our goal is to improve quality of life for the millions of people who suffer from rotator cuff disease by treating patients earlier and potentially preventing the progression of disease,” Martha Shadan, president and chief executive officer of Rotation Medical, stated in a company press release. “This regulatory clearance enables us to begin to commercialize our bioinductive scaffold solution, and we expect to launch in the U.S. later this year.”