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Orthopedic and Dental Industry News

February 2013

Musculoskeletal News Roundup 28-Feb-13 BY ANDREW VAHRADIAN, FEBRUARY 28, 2013

Alphatec Spine, Artimplant AB, Anika Therapeutics, Exactech, Globus Medical, Mako Surgical, NuVasive report financial results for 4Q:12...Vexim acquires new technological system for the injection and mixing of orthopedic cement...FDA initiates Class I recall for Johnson & Johnson's LPS Diaphyseal Sleeve system...SpineGuard receives regulatory approval to market its PediGuard Platform in Russia...Premia Spine, Zimmer Spine launch new products...Amedica Corporation receives new patent for artificial spinal disc implant...Spineart announces launch of its direct sales and distribution Italian subsidiary...Symmetry Surgical enters into a distribution agreement with Hospital Innovations...Arcam AB and DiSanto Technology agree to a new strategic alliance...Tornier appoints David Mowry as new CEO more

Medical Device Regulation Change in Argentina BY ANDREW VAHRADIAN, FEBRUARY 28, 2013

The Administracion Nacional de Medicamentos, Alimentos and Tecnologia Medica (ANMAT), the Argentinean medical device market regulator, has ratified a number of modifications regarding the country's General Law for Medical Devices, affecting various components of the device registration process and approval... more

David Mowry Appointed CEO of Tornier N.V. BY ANDREW VAHRADIAN, FEBRUARY 27, 2013

Tornier N.V. announced that its Board of Directors has appointed David H. Mowry as the company's President and Chief Executive Officer. Mr. Mowry, who has been serving as interim CEO since Douglas Kohrs retired from the role in November, joined... more

Dental News Roundup BY MATTHEW JAFFE, FEBRUARY 26, 2013

Earnings Zimmer reported dental sales of $61 million, down 2% for 4Q:12. For the year Zimmer Dental had $238 million in sales, down 2% from last year. The company stated the decline was due to slower growth in a number... more

Musculoskeletal News Roundup 22-Feb-13 BY ANDREW VAHRADIAN, FEBRUARY 22, 2013

Integra LifeSciences, LISI Medical, Medtronic, Orthofix, Symmetry Medical, Tornier, Wright Medical report financial results...Dallen Medical receives 510(k) clearance for its Compressyn Staple...DePuy receives field safety notice for its ADEPT 12/14 Modular Head...Integra LifeSciences receives warning letter from FDA related to quality systems issues at Puerto Rican facility...DePuy Synthes launches its GLOBAL UNITE Platform Shoulder Arthroplasty System...ulrich medical announces U.S. market release of its flamenco Universal Spinal Fixation System more

FDA Issues Draft Guidance on Third-party Device Review Program BY ANDREW VAHRADIAN, FEBRUARY 22, 2013

The FDA issued a new draft guidance document regarding the accreditation process for medical device companies utilizing its Third Party Review Program (TPRP). The draft aims to establish a regulatory framework that will be consistent with third party parameters currently... more

European Medical Device Industry Scrutinizes Proposed European Commission Regulatory Modifications BY ANDREW VAHRADIAN, FEBRUARY 20, 2013

Through the industry association Eucomed, the European medical device industry (Industry) has issued a position paper that assesses a number of modifications the European Commission has proposed to assimilate within the European Union's Medical Device Directives. In the paper, Eucomed... more

Musculoskeletal News Roundup 15-Feb-13 BY ANDREW VAHRADIAN, FEBRUARY 15, 2013

Blue Belt announces first NavioPFS Unicondylar Knee Replacement surgery performed in the US...ArthroCare, CONMED, DJO Global, Smith & Nephew report financial results for 4Q...Oxford Performance Materials, Planmed Oy, Stanmore Implants receive 510(k) clearance from FDA...Instratek, Kimberly-Clark, Metric Medical Devices launch new products...Stryker awarded $70 million in patent infringement suit against Zimmer...Vexim establishes new UK subsidiary more

Blue Belt Technologies announces the first NavioPFS Unicondylar Knee Replacement surgery performed in the US BY EDITOR, FEBRUARY 14, 2013

Blue Belt Technologies, Inc., the innovative medical technology company that markets its NavioPFS orthopedic surgical system with precision robotics for unicondylar knee replacement, today announced the first three Unicondylar Knee Replacement (UKR) surgeries performed in the U.S. with the NavioPFS... more

Japanese Regulators Call for Swifter Device Approval Timeframes BY ANDREW VAHRADIAN, FEBRUARY 12, 2013

The Health, Labor & Welfare Ministry of Japan plans to propose a bill allowing up to 60% of the country's Class III medical devices such as kidney dialysis machines and generic dental implant products, to be eligible for the new... more

Researchers Develop Material with the Potential to Promote Bone Formation BY ANDREW VAHRADIAN, FEBRUARY 11, 2013

Researchers at the Universities of Edinburgh and Southampton have discovered an amalgamation utilizing stem cells and a new lightweight plastic that can support bone formation. In the study, published in Advanced Functional Materials, the researchers determined that by combining bone... more

Musculoskeletal News Roundup 8-Feb-13 BY ANDREW VAHRADIAN, FEBRUARY 8, 2013

Mathys AG Bettlach reports results for 2012...K7 LLC receives 510(k) clearance for its K7C Cervical Spacer...Mazor Robotics receives approval to market its Renaissance system in Canada and Taiwan...Breg announces the launch of four new products...Medtronic introduces the first MRI compatible spinal cord stimulators in Europe...HydroCision announces study results of its Hydrodiscectomy procedure...Mako Surgical awards Rebound Orthopedics & Neurosurgery grant for two studies...Medtronic launches test of its Multicolumn Implantable Lead Stimulation for Low Back Pain device...Smith & Nephew Orthopedics terminates 100 jobs in Massachusetts...SpinalCyte names Dr. Jeffrey Geesin to its Clinical Advisory Board. more

CMS Publishes Final Sunshine Act Rule BY ANDREW VAHRADIAN, FEBRUARY 8, 2013

The Centers for Medicare and Medicaid Services (CMS) announced the long-awaited Final Rule of the Physician Payments Sunshine Act (Sunshine Act), which will raise public awareness of the financial relationships between medical device and pharmaceutical companies and doctors and teaching... more

Researchers Conclude the "July Effect" is Negligible on Spinal Surgery BY ANDREW VAHRADIAN, FEBRUARY 6, 2013

Researchers concluded that the storied "July Effect", which claims that patients receive a lower standard of care due to the introduction of new residents and fellows at teaching hospitals during the month of July, has an negligible effect on periprocedural... more

Musculoskeletal News Roundup 1-Feb-13 BY ANDREW VAHRADIAN, FEBRUARY 1, 2013

Blue Belt announces the first U.S. sale of its NavioPFS system...ulrich medical, Zimmer report 4Q:12 and annual results...Bone Therapeutics, Osseon Therapeutics, OsteoVantage, SpinalMotion all receive financing...Conventus Orthopaedics receives 510(k) clearance for its DRS Implant...DEFINE, Inc. launches its StabiliT ERX Bone Cement...JointMetrix Medical announces development of new remote monitoring technology...The Steadman Philippon Research Institute publishes study on "Package" rehabilitative approach...Zyga Technology completes GLISSADE Trial enrollment...Amedica announces four new senior position appointments more

Complete Archive