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Orthopedic and Dental Industry News

June 2012

Breaking: Supreme Court Upholds Healthcare Reform BY LAUREN UZDIENSKI, JUNE 28, 2012

The Supreme Court today upheld healthcare reform, ruling that the individual mandate was effectively a tax and as thus was constitutional. The individual mandate was considered one of the critical issues of the constitutionality of President Obama's legislation. One more minor provision was struck, having to do with state Medicaid funding, though most of the legislation will stand. more

Musculoskeletal News Roundup 28-Jun-12 BY LAUREN UZDIENSKI, JUNE 28, 2012

Benvenue raises $25M ... ZMH launches TM Ardis Interbody System for the lumbar spine ... Cartiva completes enrollment for their MOTION trial ... Corin expands LARS distribution agreement ... IART debuts private label version of the aap Implantate stainless headed compression screw system more

FDA to Review Metal-on-Metal Data This Week BY LAUREN UZDIENSKI, JUNE 27, 2012

Today the FDA's Orthopaedic and Rehabilitation Devices Panel will convene to review safety and efficacy data on metal-on-metal hips. The panel will look at data from published MoM literature as well as registry data from around the world. more

BMTI's Positive Canadian Augment Data BY LAUREN UZDIENSKI, JUNE 25, 2012

At the American Orthopaedic Foot and Ankle Society annual meeting last week, BioMimetic Therapeutics noted positive results from an Augment Injectable Bone Graft registration study, conducted in Canada on foot and ankle fusion cases. The study, which will support a Canadian Device License application, met its primary endpoint of non-inferiority of AIBG to autograft as assessed by CT scan at six months. more

Musculoskeletal News Roundup 21-Jun-12 BY LAUREN UZDIENSKI, JUNE 21, 2012

Biomet pre-announces ... BONESUPPORT raises $10M ... Biomet announces initial closing of DePuy trauma transaction ... FDA clears KFx Medical's 5mm AppianFx Tissue Fixation Anchor ... Integra launches IPP-ON PIP Fusion System more

Von Eschenbach Calls for a "Modernized" FDA BY LAUREN UZDIENSKI, JUNE 20, 2012

In an editorial published by the Wall Street Journal, former FDA commissioner Andrew Von Eschenbach said a "modernized" FDA would get devices more quickly to the patients who need them and better equip the agency to track the devices once they're on the market. Without change, the authors write, patients will continue to face illness, disability and even death while they wait, and the innovation will be incentivized to move overseas. more

FDA Seeks More Information from Anika on Monovisc BY LAUREN UZDIENSKI, JUNE 19, 2012

Anika Therapeutics disclosed in an 8-K last week that they met with the FDA to address a non-approvable letter for Monovisc. more

Blue Belt Technologies' NavioPFS Surgical System Earns Frost & Sullivan's 2012 Global Orthopedic Surgery Technology Innovation Award BY EDITOR, JUNE 18, 2012

Blue Belt Technologies, Inc. announced that its NavioPFS Orthopedic Surgical System has received the Frost & Sullivan 2012 Global Orthopedic Surgery Technology Innovation Award. more

CDRH's Shuren Touts Improvements in FDA Process BY LAUREN UZDIENSKI, JUNE 14, 2012

In comments delivered in Memphis this week, CDRH Director Jeff Shuren announced that efforts to improve efficiency and speed up the regulatory process are paying off. Dr. Shuren said that decision times are decreasing and the FDA is engaging in less back-and-forth with devicemakers, and that progress will only continue with the support from the newly-authorized MDUFA III. "The good news is we're seeing the canary in the coal mine is actually singing these days," Shuren said of the CDRH. more

Musculoskeletal News Roundup 14-Jun-12 BY LAUREN UZDIENSKI, JUNE 14, 2012

J&J/Synthes transaction closes ... ConforMIS raises $73M ... Mazor announces Korean regulatory approval for Renaissance ... FDA clears TransCorp's SpinePort Spinal Access System ... SANUWAVE announces preclinical osteoarthritis results ... Internal Fixation System launches GoDirect sales program ... Premier awards spine contracts more

Synthes Acquisition to Close as FTC Approves Deal BY LAUREN UZDIENSKI, JUNE 12, 2012

The final hurdle to the closing of J&J's acquisition of Synthes has been cleared, as the FTC announced yesterday that they would approve the transaction. As announced previously, Synthes plans to divest its trauma line to Biomet to reduce anti-trust concerns. The FTC specified the DVR system for treating distal radius fractures as a particular issue and one of the products that would be sold to Biomet. more

Device Tax Repeal Expected to Stall in Senate BY LAUREN UZDIENSKI, JUNE 11, 2012

The House voted to pass device tax repeal legislation last week, but companion legislation is not expected to pass the Senate, and President Obama has threatened a veto if the bill reaches his desk. more

Mindray Medical to Acquire Controlling Stake in Wuhan Dragonbio Surgical Implant Co. BY LAUREN UZDIENSKI, JUNE 8, 2012

Yesterday Mindray Medical announced plans to acquire a controlling stake of Wuhan Dragonbio Surgical Implant Co., Ltd., a Chinese medical orthopedic products provider that specializes in trauma, spine, joint and other surgical products. Mindray will pay approximately $35.5 million in cash for the share in Dragonbio, which recorded $7.7 million in sales in 2011. more

Musculoskeletal News Roundup 7-June-12 BY LAUREN UZDIENSKI, JUNE 7, 2012

J&J/Synthes deal may close next week ... Mindray to acquire controlling interest in Chinese orthopedic manufacturer ... FDA clear's Medicrea's LigaPASS ... K2M launches MESA Small Suture implant ... SNN voluntarily withdraws the optional metal liner component of its R3 Acetabular System ... ISTO receives U.S. patent ... SYK close to settling DOJ investigation into OtisKnee ... SANUWAVE comments on preclinical data more

Biomet Weighs Dental Spin-Off BY LAUREN UZDIENSKI, JUNE 5, 2012

Biomet reported in a regulatory filing that they are beginning to "pursue strategic exploratory work" relating to a tax-free spin-off of Biomet 3i, the company's dental division. The company said they expect this effort to take several months and they would not comment further "unless and until a decision is made." more

John Chopack Named to MDDI's 40 Medtech Innovators Under 40 BY EDITOR, JUNE 5, 2012

HealthpointCapital Managing Director John Chopack was named to MDDI's list of 40 Medtech Innovators Under 40. The list recognized future industry leaders who are developing novel technologies and supporting innovative companies. more

House to Vote on Device Tax Repeal BY LAUREN UZDIENSKI, JUNE 4, 2012

Last week the House Ways & Means Committee voted 23-11 to repeal the 2.3% medical device tax, set to go into effect January 1. Now that the legislation has passed committee, the bill will go to the House floor for a vote. The Protect Medical Innovation Act, introduced by Minnesota rep Erik Paulsen, may reach a vote as early as this week. more


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