Biorez Announces FDA 510(k) Clearance of Its Proprietary BioBrace™ Implant Technology (press release)
Biorez Inc., a New Haven start-up advancing tendon and ligament healing, announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for two sizes of its BioBrace Implant. This new biocomposite soft tissue scaffold is intended to be used in a broad range of surgical procedures to reinforce soft tissue where weakness exists, and can be used with existing surgical techniques and instrumentation.
“We expect BioBrace to be a game-changing technology fo...