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See today's BioWorld MedTech
Home » FDA grants de novo approval of first new treatment for ACL tears in 30 years
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FDA grants de novo approval of first new treatment for ACL tears in 30 years

Dec. 22, 2020
By Annette Boyle
Miach Orthopaedics Inc. got a leg up on competitors with the U.S. FDA's de novo approval of its Bridge-Enhanced ACL Repair (BEAR) implant. The company achieved a long-term goal in orthopedics, developing a graft-free system that enables the anterior cruciate ligament (ACL) to repair itself. The device represents the first new treatment for ACL tears in three decades.
BioWorld MedTech Regulatory Orthopedics De novo FDA

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