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.
Edwards Lifesciences Corp. launched a pivotal trial of its mitral valve repair system in the U.S., with the first patient undergoing treatment for severe degenerative mitral valve regurgitation at the University of Maryland Medical Center in Baltimore. Open-heart surgery is the current standard approach to mitral valve repair, but the Harpoon Beating Heart mitral valve repair system allows surgeons to use a minimally invasive approach, according to Edwards Lifesciences.
Bayer Corp. and Veracyte Inc. are collaborating in the thyroid cancer space, with an eye toward identifying underlying genomic drivers, including NTRK gene fusions, within patients’ tumors. South San Francisco-based Veracyte offers the Afirma Genomic Sequencing Classifier (GSC) and Xpression Atlas (XA), which aims to help physicians in terms of thyroid cancer diagnosis and individualized care.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acell, Artms, Medtronic, Products + Features, Quidel, Rapid Medical.
Keeping you up to date on recent developments in oncology, including: Multicancer screening paradigm bolstered in new study; Potentiating PARP inhibitors; New non-viral vector siRNA approach described; NICE nods to combo therapy for HCC.
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