July 09, 2023
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Inovedis receives FDA clearance of rotator cuff implant system
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Key takeaways:
- Inovedis GmbH has announced FDA clearance of its Sinefix rotator cuff repair implant system.
- The company will launch the product at the American Orthopaedic Society for Sports Medicine Annual Meeting.
Inovedis GmbH has announced FDA clearance of Sinefix, an implant system for patients undergoing surgery for rotator cuff tears, according to a press release.
Sinefix is a staple implant that creates flat and even contact of tendon and bone while maintaining blood circulation and facilitating healing, according to the release.
“With FDA clearance, we will now initiate a first mover application to generate real-world experience in the U.S. to evaluate the potential of the technology,” Lukas Flöss, founder and CEO of Inovedis GmbH, said in the release.
The company plans to launch the Sinefix system at the American Orthopaedic Society for Sports Medicine Annual Meeting in Washington, D.C., from July 13 to July 16.
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