Approval
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Spine
Ortho Kinematics Secures CE Mark Approval to Support International Expansion
AUSTIN, Texas–(BUSINESS WIRE)–Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostics company focused on spine imaging informatics, announced today it…
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Hospitals
Safe Orthopaedics expands its business to the Asia-Pacific region by entering into a distribution agreement covering Australia and New Zealand
Eragny-sur-Oise, April 13, 2016 – SAFE ORTHOPAEDICS (Euronext: FR0012452746 – SAFOR), a company developing and marketing an innovative range of…
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Spine
EOS imaging Receives FDA Approval for spineEOS, its online 3D Planning Solution for Spine Surgery
Paris, April 12, 2016 – EOS imaging (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, announced today…
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Extremities
Anika Therapeutics Wins CE Mark Approval for Cingal® for the Treatment of Pain Associated with Osteoarthritis of the Knee
BEDFORD, Mass.–(BUSINESS WIRE)– Anika Therapeutics, Inc., (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its…
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Hospitals
Senate committee proposes easier approval process for medical devices
The U.S. Senate Committee on Health, Education, Labor and Pensions favorably reported a measure today that would reduce regulatory hurdles…
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Hospitals
InVivo Therapeutics Announces Approval for INSPIRE Pivotal Probable Benefit Clinical Study of the Neuro-Spinal Scaffold™
CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) announced that it has received approval of a protocol amendment from the U.S. Food…
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Hospitals
InVivo Therapeutics receives conditional FDA approval for INSPIRE pivotal probable benefit study
InVivo Therapeutics announced the FDA has given the company conditional approval to convert an ongoing study into the pivotal probable…
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CareFusion receives two 510(k) clearances for spine augmentation devices
CareFusion announced the FDA 510(k) clearances for its 13-gauge AVAmax vertebral balloon system and its 11-gauge AVAmax vertebral balloon system.…
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Hospitals
Medtronic Announces FDA Approval of Infuse® Bone Graft for Three New Spine Surgery Indications
December 11, 2015 – Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval of additional spine…
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Hospitals
CareFusion Receives Two 510(k) Clearances For Spine Products
FRANKLIN LAKES, N.J., Dec. 10, 2015 /PRNewswire/ — CareFusion, a BD company (BDX), today announced the U.S. Food and Drug Administration…
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Greatbatch receives FDA approval for spinal cord stimulation system
Greatbatch Inc. recently announced it has received FDA approval for its Algovita Spinal Cord Stimulation System to treat chronic intractable…
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Uncategorized
Amplitude Surgical announces additional regulatory approvals in Australia
November 23, 2015 12:00 PM Eastern Standard Time VALENCE, France–(BUSINESS WIRE)–Regulatory News: Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME…
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Hospitals
Dabigatran approved for DVT, PE prophylaxis after hip replacement surgery
Boehringer Ingelheim announced that the FDA has approved a new indication for dabigatran to prevent deep vein thrombosis or pulmonary…
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Hospitals
39 orthopedic, spine devices receive FDA 510(k) clearance in October
By Laura Dyrda The Food and Drug Administration granted 39 orthopedic- and spine-related clearances in October. 1. Valeo Spacer System and Valeo…
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Hospitals
Prosidyan Announces FDA 510(k) Clearance of FIBERGRAFT BG Morsels for Postero-Lateral Spinal Fusion
Warren, NJ, November 16, 2015 –(PR.com)– NJ-based Prosidyan (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, announced today that it…
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