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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

September 2010

Dental News Roundup September 2010 BY LAUREN UZDIENSKI, SEPTEMBER 30, 2010

Straumann launches new CAD/CAM portfolio . . . VITA expands shade range . . . EPA may require dentists to recycle mercury waste . . . BIOLASE increases sales force . . . Zimmer Dental to distribute RTI biologics worldwide . . . Sirona announces management changes more

Musculoskeletal News Roundup 30-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 29, 2010

InVivo Therapeutics planning a reverse merger . . . MiMedx to raise $5.0 million . . . FDA clears ArthroCare's Parallax device to treat VCFs . . . Osseon Therapeutics announces 1,000-patient milestone . . . AAOS releases clinical guidelines for vertebroplasty and kyphoplasty . . . ProChon reports BioCart Autologous Cartilage System outcomes . . . RepRegen releases in vivo StronBone data more


The New York Times reports this morning on a hereditary predisposition to ACL tears. A study published in the British Journal of Sports Medicine noted several risk factors for ACL tears that were common between twins, furthering data from a year earlier that identified specific genetic markers that correlated to knee injuries. more

AdvaMed: FDA's Class IIb Proposal is Too Broad BY LAUREN UZDIENSKI, SEPTEMBER 27, 2010

When the FDA released a list of proposed changes to the 510(k) process, AdvaMed praised the agency for incorporating a new class IIb designation for devices that may require additional data. However, as more information emerged about the scope of class IIb, AdvaMed withdrew their support, noting that they recommended additional controls for a "small, focused" subset of devices narrower than what the FDA seems to have in mind. more

MEDCAC Vote on Off-Label BMP Use Shows Lack of Confidence in Supporting Evidence BY SANDER DUNCAN, SEPTEMBER 23, 2010

On Wednesday, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) met to discuss the existing body of evidence on BMPs, particularly when it is used off-label. The panel's vote on their confidence in the adequacy of the data published... more

Musculoskeletal News Roundup 23-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 23, 2010

M&A Amedica acquired US Spine for an undisclosed amount. The target company manufactures a range of fusion products as well as the Facet Fixation System, which features the Facet Gun to lock the facet joint. Amedica says that with the... more

Cortoss IDE Data Published in Spine BY LAUREN UZDIENSKI, SEPTEMBER 21, 2010

Orthovita announced the publication of data from their Cortoss IDE studies in the journal Spine. more

Amedica Acquires US Spine BY LAUREN UZDIENSKI, SEPTEMBER 21, 2010

Amedica has broadened its spinal portfolio, acquiring US Spine for an undisclosed amount. more

FDA and CMS Propose Simultaneous Reviews BY LAUREN UZDIENSKI, SEPTEMBER 20, 2010

The FDA and CMS are considering overlapping reviews of new products, which the agencies say could reduce the time between marketing and reimbursement decisions. more

Musculoskeletal News Roundup 16-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 16, 2010

NUVA lowers guidance . . . HydroCision acquired by three VC firms; new President and CEO appointed . . . TiGenix closes seed financing round for new pharma spinoff . . . Creaspine, Ranier Technology receive CE mark clearances . . . Medtronic introduces Kyphon Cement Delivery System in Europe . . . SpineAlign Medical introduces European Observational Registry for the VerteLift System . . . Medtronic wins certain rulings in ongoing patent infringement suit brought by Synthes . . . Synthes sues Biomet, former sales rep more

Amid Industry Concerns, FDA User Fees to Increase Oct. 1 BY LAUREN UZDIENSKI, SEPTEMBER 15, 2010

The FDA will increase medical device user fees by 8.5% starting October 1. User fees, which have been in place since 2002, contribute to funding device reviews and are designed to get devices to market more quickly, though the FDA has struggled to meet performance goals. more

Venture Capitalists Launch Lobby for Life Science Innovation BY LAUREN UZDIENSKI, SEPTEMBER 14, 2010

The National Venture Capital Association announced this week the launch of the Medical Innovation and Competitiveness (MedIC) Coalition, a new healthcare lobby dedicated to furthering U.S. medical innovation and "[protecting] the country's global leadership position in the life sciences industry." more

RTI Biologics Licenses Adult Stem Cell Technology BY LAUREN UZDIENSKI, SEPTEMBER 13, 2010

RTI Biologics announced a collaboration with Athersys this morning, whereby RTI will have access to Athersys' Multipotent Adult Progenitor Cell (MAPC) technology. RTI plans on developing the cells for orthopedic applications. more

Musculoskeletal News Roundup 9-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 9, 2010

Amedica raises $30M . . . BioMimetic affirms Augment PMA timeline . . . Aesculap, K2M announce 510(k) clearances . . . BMTI and Eden Spine announce U.S. and EU patents . . . Tornier announces early clinical results more

BMPs Used Off-Label in 85% of Cases BY LAUREN UZDIENSKI, SEPTEMBER 8, 2010

A new study in Spine documents the rise of BMPs and the prevalence of off-label use, demonstrating that between 2003 and 2007, the annual number of procedures utilizing BMPs increased 4.3-fold from 23,900 to 103,194. Of those, 85% were identified as off-label uses of the material. more

Bisphosphonates May Raise Risk of Esophageal Cancer BY LAUREN UZDIENSKI, SEPTEMBER 8, 2010

A new study in the British Medical Journal concluded that oral bisphosphonates, a class of osteoporosis drugs that includes Fosamax, Boniva and Zometa, may be associated with doubled risk of esophageal cancer. more

Infection Risk in Musculoskeletal Cases BY LAUREN UZDIENSKI, SEPTEMBER 7, 2010

Though infections currently affect only a fraction of musculoskeletal patients, they do increase costs and lead to poorer outcomes, as emphasized in a new review article in JBJS. Infections can be attributed to a number of reasons, including resistant pathogens, hospital overcrowding and understaffing and inadequate hand-washing, and despite policy initiatives designed to prevent infection, the authors caution that infection rates are projected to increase in the coming decades. more

Musculoskeletal News Roundup 2-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 2, 2010

Sanofi-aventis makes bid for Genzyme . . . Orthofix obtains new credit facility . . . Mazor Surgical adds 3D imaging to SpineAssist . . . CDRH's 510(k) director to retire . . . Amedica, TiGenix announce new U.S. patents . . . U.S. News and World Report names top orthopedic hospitals more

Mazor to Market Combined SpineAssist, 3D Imaging System BY LAUREN UZDIENSKI, SEPTEMBER 1, 2010

Mazor Surgical received FDA clearance to market the SpineAssist robotic surgical system and the C-Insight 3D imaging system as one unit. more

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