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March 14-18 - American Association of Orthopaedic Medicine Annual Meeting 2017

March 14-December 31 - Canaccord Genuity Musculoskeletal Conference

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Orthopedic and Dental Industry News

December 2012

FDA Reports Shorter Device Review Times BY LAUREN UZDIENSKI, DECEMBER 24, 2012

Two years ago, the FDA announced plans to modernize their device division, aiming to minimize review times and simplify the regulatory process. Now the agency reports progress on their initiatives, with 510(k) review times decreasing for the first time since 2005, the 510(k) backlog reduced by two-thirds and the PMA review time decreasing by one-third. Further, the percentage of devices being approved is increasing, a sign of "improvements in the quality of applications and the consistency of review standards." more

Musculoskeletal News Roundup 20-Dec-12 BY ANDREW VAHRADIAN, DECEMBER 20, 2012

Ortho Kinematics raises $2 million in Series B financing...TiGenix raises $8.9 million through accelerated bookbuilding private placement procedure...Ascendx Spine receives 510(k) clearance for its Ascendx VCF Repair System...NuVasive receives Shonin clearance for its CoRoent Impacted and Tapered titanium alloy implants...Smith & Nephew announce component extension to its LEGION Total Knee System...Zimmer Spine initiates voluntary recall of its PEEK Ardis Inserter...Trans1 awarded patent for "prosthetic nucleus with a preformed membrane" more

International Market Prospects for Robotics BY ANDREW VAHRADIAN, DECEMBER 18, 2012

Through telemedicine, robotics give surgeons the ability to perform minimally invasive and complex surgeries precisely from anywhere in world. This kind of versatility and acclimation has much to offer emerging markets still developing their medical systems, a trend that is... more

Australia and New Zealand Progress with Plan to Implement Joint Regulatory System for Medical Devices BY ANDREW VAHRADIAN, DECEMBER 17, 2012

Australian and New Zealander ministers reported progress from a second meeting of the Implementation Ministerial Council. This group aims to launch a new medical device regulatory body called the Australia New Zealand Therapeutic Products Agency (ANZTPA). Once operational, ANZTPA will... more

Musculoskeletal News Roundup 13-Dec-12 BY ANDREW VAHRADIAN, DECEMBER 13, 2012

Blue Belt Technologies receives 510(k) clearance from the FDA for its NavioPFS Surgical System...Cerapedics raises $19 million in Series C funding...Boston Scientific receives CE Mark approval for its Precision Spectra Spinal Cord Stimulator System...Precision Spine receives 510(k) clearance from the FDA for its Mini-Max Minimally Invasive Access System...Medtronic announces launch of its CERVICAL FACETLIFTSM ID/S surgical technique...Misonix terminates distribution agreement with Aesculap... more

Senators Urge for Delay of Medical Device Tax as Repeal Efforts Persist BY ANDREW VAHRADIAN, DECEMBER 13, 2012

Senators Amy Klobuchar (D - Minnesota) and Kay Hagan (D - North Carolina) have authored a letter, signed by 16 additional current and elected senators, asking Senate Majority Leader Harry Reid, for support in delaying the start date of the... more

Blue Belt Receives 510(k) Clearance for NavioPFS Surgical System BY EDITOR, DECEMBER 10, 2012

Blue Belt Technologies Receives FDA Clearance to Market its NavioPFS Surgical System for Unicondylar Knee Replacement Surgery PITTSBURGH, PA. (December 10, 2012) - Blue Belt Technologies, Inc., an innovative medical technology company focused on commercializing a precision robotic solution for... more

Musculoskeletal News Roundup 7-Dec-12 BY ANDREW VAHRADIAN, DECEMBER 7, 2012

Innovative Trauma Care raises $3.6 million...2IL extends acceptance period for its acquisition of Corin Group...FDA upholds initial non-approvable decision on Anika's Monovisc product...FzioMed files for reconsideration with the FDA on its Oxiplex Gel product...Covidien announce launch of AS Meniscal Repair Device more

Off-label Drug Promotion Upheld by Federal Court BY ANDREW VAHRADIAN, DECEMBER 7, 2012

A U.S. Court of Appeals has ruled that the FDA's ban on the off-label promotion of drugs between physicians and medical sales representatives violates a person's First Amendment right to free speech. The three-judge panel came to a 2-1 majority... more

Medtech Tax - Little Has Changed BY JOHN MCCORMICK, DECEMBER 6, 2012

The Internal Revenue Service has recently posted final regulations on the medical device excise tax that was crafted to help offset the cost of Obamacare. As background, the federal government enacted into law a 2.3% tax on U.S. medical device... more

Medtronic and Weigao End Distribution Joint Venture BY ANDREW VAHRADIAN, DECEMBER 3, 2012

Medtronic and Weigao have decided on an early end for their distribution joint venture, Medtronic Weigao Orthopaedic ("JV"), which distributes orthopedic implants, instruments and devices in China, initiated in December 2007. This realignment by Medtronic is not surprising as the... more


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