fda clearance
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Extremities
Zebra Medical Vision Secures a 7th FDA Clearance for Its Patented Breakthrough in Orthopedic Surgery Planning
The recently patented medical imaging company’s AI solution extracts exact 3D bone reconstruction from X-ray scans at the same quality…
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Recon
THINK Surgical® Receives FDA Clearance of Second-Generation Active Robot
FREMONT, Calif., Nov. 20, 2020 /PRNewswire/ — THINK Surgical, an innovator in the field of orthopedic active robot surgery, announced today that the…
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Extremities
Nvision Biomedical Technologies: First FDA Clearance for Osteotomy Wedge System Made of PEEK-OPTIMA™ HA Enhanced
THORNTON CLEVELYS, UK – (October 28, 2020) — Nvision Biomedical Technologies, a San Antonio, Texas-based medical device and implant manufacturer,…
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Extremities
FDA Clearance Granted To Wishbone Medical’s Pediatric External Fixation System
WARSAW, Ind., Oct. 13, 2020 (GLOBE NEWSWIRE) — WishBone Medical, Inc., a leader in pediatric orthopedic medical devices, today announced…
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Extremities
FH Ortho Receives FDA Clearance for Telegraph Evolution Humeral Nail System
CHICAGO, Oct. 13, 2020 (GLOBE NEWSWIRE) — FH Ortho Inc, a well-established innovative orthopedic medical device company, is pleased to…
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Extremities
IlluminOss Medical Receives FDA Clearance for Use in Fibula Fractures
EAST PROVIDENCE, R.I., Aug. 18, 2020 /PRNewswire/ — IlluminOss Medical, a medical device company focused on minimally invasive orthopedic fracture repair, today announced that…
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Extremities
Anika To Launch Six FDA-Cleared Sports Medicine and Extremities Products in Third Quarter of 2020
BEDFORD, Mass., July 20, 2020 (GLOBE NEWSWIRE) — Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated joint preservation, restoration and regenerative solutions…
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Extremities
Paragon 28, Inc. is pleased to announce that the U.S. Food and Drug Administration has cleared the APEX 3D™ Total Ankle Replacement System
ENGLEWOOD, Colo., July 14, 2020 /PRNewswire/ — APEX 3D™ marks the next generation in Total Ankle Arthroplasty, with advanced technologies such as porous…
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Recon
Medacta to Introduce NextAR(TM): First FDA-Cleared Augmented Reality-Based Surgical Platform for Total Knee Replacement
CASTEL SAN PIETRO, 13 July 2020 – Medacta today announced it has received clearance from the U.S. Food and Drug Administration…
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Biologics
Baxter Announces U.S. FDA Clearance of Altapore Shape Bioactive Bone Graft for Use in Surgery
July 9, 2020 DEERFIELD, Ill.–(BUSINESS WIRE)–Baxter International Inc. (NYSE:BAX), a global leader in advancing surgical innovation, today announced U.S. Food…
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Regulatory
Spinal Elements® Announces FDA Clearance of Sapphire® X Anterior Cervical Fixation System
July 2, 2020 CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a Carlsbad, CA-based medical device company focused on spine surgery procedures, today announced…
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Biologics
Bioventus Receives FDA Clearance of Strip Format of its SIGNAFUSE® Bioactive Bone Graft
June 25, 2020 DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, is launching its SIGNAFUSE Bioactive Bone Graft in a new…
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COVID-19
FDA OKs emergency approval for coronavirus test kit created by Massachusetts-based company
May 8, 2020 / By Kayla Rivas | Fox News The U.S. Food and Drug Administration has issued an Emergency Use Authorization…
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Regulatory
Camber Spine Technologies Announces Nationwide Launch of SPIRA®-C Integrated and FORTICO™ Anterior Cervical Plate
SPIRA®– C Integrated – stand-alone integrated cervical fixation system FORTICO™ Anterior Cervical Plating System KING OF PRUSSIA, Pa., May 7, 2020 /PRNewswire/…
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