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Orthopedic and Dental Industry News
March 2013Musculoskeletal News Roundup 28-Mar-13 BY ANDREW VAHRADIAN, MARCH 28, 2013Blue Belt NavioPFS System purchased by Tri-City Medical Center and featured on ABC News program...Medrobotics raises $10 million in debt financing...Health Canada finalizes guidelines for classifying therapeutic products in Canada...China’s State Food and Drug Administration (SFDA)renames itself the China Food and Drug Administration (CFDA)...Egypt's Central Administration for Pharmaceutical Affairs (CAPA) updates registration requirements for med devices...Regulatory authorities in Australia and New Zealand launch joint early warning system...K2M, Shoulder Options launch new products...BONESUPPORT along with the University of Mainz announce the CERTiFy study...OsteoVantage opens office at the University of Missouri - St. Louis more The USPTO Takes Major Step Towards Harmonizing U.S. Patent Law with Foreign Patent Procedures BY ANDREW VAHRADIAN, MARCH 28, 2013With the final implementation of the "first-inventor-to-file" provision of the Leahy-Smith America Invents Act (AIA) ratified on March 16, 2013, the United States Patent and Trademark Office (USPTO) has taken a major step towards revising the U.S. patent process and... more Blue Belt NavioPFS System Purchased by Tri-City Medical Center and Featured on ABC News Program BY EDITOR, MARCH 25, 2013Tri-City Medical Center announced that it has purchased Blue Belt Technologies' NavioPFS System in order to provide partial knee replacements resulting in less invasive, faster procedures with quicker recovery times for patients who suffer from debilitating arthritis pain. The NavioPFS... more Musculoskeletal News Roundup 22-Mar-13 BY ANDREW VAHRADIAN, MARCH 22, 2013OrthoAccel Technologies receives approval to distribute AcceleDent to the Canadian market...Senate votes in favor of repealing the Affordable Care Act's 2.3% medical device excise tax...GS Medical, Mazor Robotics, Vexium report financial results...EOS imaging, Integra LifeSciences, NuVasive, Regentis Biomaterials, X-Spine all received product clearances...CONMED, DePuy Synthes, DJO Global, Exactech, Intregra LifeSciences, Invuity, LifeNet Health, Mitek Sports Medicine, Orthofix, Smith & Nephew, STERIS Corporation, Stryker, Zimmer all announce product launches...DSM enters license and supply agreement with SpineVision...Hatch Medical receives two patents...Amedica, Benvenue Medical, Mako Surgical, RTI Biologics release new studies...aap Implantate forms joint venture with eontec Co., Ltd...aap Implantate signs license deal with BiosCompass, Inc...Biomet and OrhtoSensor announce co-promotion partnership...SafeWire, LLC announces the appointment of Sean Kane as VP of Sales...Zimmer announces departure of Jeffrey Paulsen, President of Global Business more Senate Votes in Favor of Repealing 2.3% Medical Device Excise Tax BY ANDREW VAHRADIAN, MARCH 22, 2013Legislation seeking to repeal the Affordable Care Act's 2.3% medical device excise tax received overwhelming support late last night in Congress. The Senate voted 79-20 in favor of revoking the 2.3% excise tax on medical device companies' device sales. Thirty-three... more Congressman Dan Maffei Introduces New Legislation Repealing the 2.3% Medical Device Excise Tax BY ANDREW VAHRADIAN, MARCH 22, 2013House Representative Dan Maffei (D-NY) introduced new legislation to Congress seeking to retract the Affordable Care Act's 2.3% medical device excise tax in its entirety. Congressman Maffei’s proposed bill named, “The Medical Device Tax Elimination Act”, completely repeals the excise... more OrthoAccel Receives Clearance to Sell AcceleDent in Canada - Delivers First Order BY EDITOR, MARCH 18, 2013OrthoAccel Technologies has received formal approval from Health Canada to distribute AcceleDent to the Canadian market. Clearance is being quickly followed with fulfilling the first order to a Canadian orthodontic practice. AcceleDent is the first FDA-cleared clinical approach to safely... more The MHRA Launches "Innovation Office" to Promote the Development of Novel Medicines and Devices in the UK BY ANDREW VAHRADIAN, MARCH 18, 2013As part of the UK government's Life Sciences Strategy, the Medicines and Healthcare products Regulatory Agency (MHRA), has launched a virtual "Innovation Office" online in order to provide advice and assistance to companies developing innovative products or exploring innovative approaches... more Musculoskeletal News Roundup 15-Mar-13 BY ANDREW VAHRADIAN, MARCH 15, 2013Alphatec Spine, Inc. receives 510(k) clearance from the FDA for its Alphatec Solus internal fixation anterior lumbar interbody fusion (ALIF) device...TiGenix reports financial results for 2012...Mesoblast completes private placement for $170 million...VertiFlex sells certain non-core assets relating to spinal implants to Stryker...CellCoTec receives CE mark approval for bio-resorbable scaffold...RTI Biologics receives 510(k) clearance for its porcine dermis implant...Aesculap, MedShape, Stryker launch new products...Lanx, Mazor Robotics announce study results...Johnson & Johnson launches new innovation center in London...Nexxt Spine relocates headquarters...NLT Spine opens subsidiary in Boston...Histogen establishes a joint venture with Southern California partners...Orthofix appoints Brad Mason as CEO more Brad Mason Appointed CEO of Orthofix International BY ANDREW VAHRADIAN, MARCH 14, 2013Orthofix International announced that its Board of Directors has appointed Brad Mason as the company's President and Chief Executive Officer, succeeding Robert Vaters who has resigned to pursue other interests. It is expected that Mr. Mason will continue to execute... more Alphatec Spine Receives FDA 510(K) Market Clearance for Its Alphatec Solus(TM) Internal Fixation Anterior Lumbar Interbody Fusion Device BY EDITOR, MARCH 12, 2013Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a company with a mission to provide physician-inspired solutions for patients with spinal disorders, announced today that the Company has received clearance from the U.S. Food and Drug Administration... more Musculoskeletal News Roundup 8-Mar-13 BY ANDREW VAHRADIAN, MARCH 8, 2013co.don and TranS1 report financial results...TranS1 acquires Baxano...Styker closes acquisiton of Trauson...Wright Medical closes acquisition of BioMimetic Therapeutics...ArthroCare receives FDA approval for PEEK implant...Mazor Robotics receives approval for commercial sale of its Renaissance navigation robot in Australia...Biomet issues safety notice for its RHK Axle and RHK Short Hinge and RHK Long Hinge Assembly components...Cerapedics, Lanx, OsteoMed, Vertebral Technologies launch new prodcuts...DFINE, Vertos Medical release new study results...Smith & Nephew products rebranded under Bioventus in certain European countires...VG Innovations appoints Mitch Hollifield as General Manager more FDA Seeks to Maintain Consistent Clinical Data Requirements BY ANDREW VAHRADIAN, MARCH 8, 2013The FDA has published a proposed rule that would require the clinical studies conducted outside the U.S. supporting medical device product registrations to be in accordance with Good Clinical Practice (GCP). These are standards upheld by the International Conference on... more TranS1 to buy Baxano BY JOHN MCCORMICK, MARCH 4, 2013This morning spinal implant maker TranS1 announced that it was merging with stenosis technology company Baxano. The deal, valued at a total of $23.6 million, is paid for primarily by TranS1 issuing new stock, although TranS1 will pay $500k of... more Complete Archive |