fda clearance
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Regulatory
Axial3D Receives FDA Clearance for Axial3D INSIGHT™ Medical Image Segmentation Platform
Cloud-based solution advances personalized healthcare through scalable, personalized 3D solutions driven by artificial intelligence. BELFAST, Northern Ireland, July 31, 2023–(BUSINESS WIRE)–Axial3D,…
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Regulatory
Inovedis Receives FDA Clearance of the SINEFIX™ Implant System for Rotator Cuff Repair
Company to Launch SINEFIX in Selected Clinical Sites in 2023 ALBSTADT, Germany, July 6, 2023 /PRNewswire/ — Inovedis GmbH, a medical technology start-up dedicated…
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Biologics
Abyrx Receives Additional FDA Clearances for MONTAGE® Settable, Resorbable Bone Putty as Bone Void Filler and Cranial Bone Cement
STAMFORD, Conn., April 5, 2023 /PRNewswire/ — Abyrx, Inc. (http://abyrx.com), a leading biomaterial sciences company with a focus on therapeutic technologies for…
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Sports Medicine
FDA Provides Clearance of First-Ever Device for ACL Reconstruction in Children
Designed to address an “epidemic” of knee injuries in younger skeletally immature athletes, the device was developed and adapted for…
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Spine
Providence Medical Technology announces FDA Clearance of the CAVUX® Facet Fixation System for the treatment of Cervical Pseudarthrosis
First integrated facet screw and cage system cleared by the FDA to revise a failed ACDF. PLEASANTON, Calif., Dec. 15, 2022 /PRNewswire/…
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