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Orthopedic and Dental Industry News

April 2011

Dental News Roundup April 2011 BY LAUREN UZDIENSKI, APRIL 28, 2011

Earnings reports from Align, Dentsply, Nobel and Straumann . . . Align receives early termination of anti-trust waiting period in its acquisition of Cadent . . . Astra Tech adds Atlantis Abutments to its abutment solutions portfolio . . . Straumann now offering VITA Mark II and TriLuxe glass ceramics in Europe more

Musculoskeletal News Roundup 28-Apr-11 BY LAUREN UZDIENSKI, APRIL 28, 2011

CNMD, IART, SYST, ZMH and more report earnings . . . FDA clears Biomet's Active Articulation E1 Dual Mobility Hip System . . . ORTHOCON receives EU, Canadian clearance to market HEMASORB . . . SI-BONE receives modification to its labeling . . . DJO Global introduces e-plus total knee replacement insert . . . Wright Medical launches FUSIONFLEX Demineralized Moldable Scaffold . . . Kuros regains certain technology rights from Baxter . . . Genzyme files two new HA infringement suits more

It's Official - J&J to Buy Synthes for $21.3B BY LAUREN UZDIENSKI, APRIL 27, 2011

In a landmark deal for orthopedics, J&J announced this morning that the company would buy Synthes for $21.3 billion. It's the biggest deal ever in orthopedics and one of the largest in healthcare. more

Alphatec Holdings Announces Appointment of Patrick Ryan as Chief Operating Officer BY EDITOR, APRIL 25, 2011

Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, today announced the appointment of Patrick Ryan as the Company's Chief Operating Officer. more

Musculoskeletal News Roundup 21-Apr-11 BY LAUREN UZDIENSKI, APRIL 20, 2011

JNJ, SYK report 1Q:11 . . . Benvenue raises $36M . . . FDA clears StelKast's Xp Acetabular Liners . . . Medtronic launches MARROWMAX Bone Marrow Aspiration Needle Kit . . . Genzyme sues Seikagaku for HA patent infringement . . . RTI to supply allograft to Alphatec more

CMS Releases Draft IPPS Rule for FY2012 BY LAUREN UZDIENSKI, APRIL 20, 2011

Yesterday afternoon, CMS released their draft IPPS rule for the upcoming fiscal year. After fairly substantial increases in pay last year, proposed pay for spine and orthopedic DRGs are moderating somewhat for FY2012. Despite a 3% increase in kyphoplasty/vertebroplasty, spine fusion looks roughly flat; further, trauma is flat, and recon is slated to receive a slight decrease in pay. more

J&J in Talks with Synthes Over Possible Acquisition BY LAUREN UZDIENSKI, APRIL 18, 2011

Synthes has confirmed rumors that the company is in talks to be acquired by J&J, reportedly for around $20 billion. more

At Senate Hearing, FDA Under Fire BY SANDER DUNCAN, APRIL 18, 2011

The Senate Special Committee on Aging held a hearing Wednesday to explore how well the FDA balances safety and innovation when approving medical devices. The hearing is part of a broader bipartisan effort to review the FDA's 510(k) approval pathway. more

Musculoskeletal News Roundup 14-Apr-11 BY LAUREN UZDIENSKI, APRIL 14, 2011

FDA approves Covidien's DuraSeal Exact . . . IART announces new spine clearances . . . Lanx launches facet screw system and ALIF system . . . Tornier introduces BioFiber Surgical Mesh . . . VITA comments on positive Vitagel data . . . Stryker sues Zimmer for allegedly poaching sales force more

Alphatec Spine to Host Technology Day May 12, 2011 in New York, NY BY EDITOR, APRIL 13, 2011

Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, today announced it will host a Technology Day for investors and analysts on Thursday, May 12, 2011. more

Biomet Announces F3Q:11 BY LAUREN UZDIENSKI, APRIL 12, 2011

Biomet announced results from their fiscal third quarter (ended February 28) this morning, and while they did not meet their goal of "sustainable above-market growth," revenues were largely stable and even demonstrated sequential improvement in trauma and spine. more

Beleaguered ReGen Files for Bankruptcy BY LAUREN UZDIENSKI, APRIL 12, 2011

Just weeks after turning down the FDA's offer for a hearing related to its Menaflex rescission and announcing that financial troubles meant the company couldn't file its annual report, ReGen Biologics filed for bankruptcy. more

Musculoskeletal News Roundup 7-Apr-11 BY LAUREN UZDIENSKI, APRIL 7, 2011

aap, Medicrea report 1Q sales . . . Orthopaedic Synergy to raise $9.5M . . . FDA clears ATEC's Solus . . . Titan Spine receives CE mark for Endoskeleton lumbar devices . . . Emerge Medical introduces trauma line . . . Life Spine holds surgeon training . . . Mazor announces 2,000th procedure . . . CareFusion's COO resigns more

IOM Completes Independent Review of the 510(k) Process BY SANDER DUNCAN, APRIL 5, 2011

The Institute of Medicine (IOM) completed its review of the FDA's 510(k) clearance protocol last week. The IOM study is the external component of an comprehensive review of the FDA's most common approval pathway for medical devices. Meanwhile, industry stakeholders are questioning the lack of medtech representatives on the IOM panel conducting the review. more

Wright Medical's CEO Resigns BY LAUREN UZDIENSKI, APRIL 5, 2011

Wright Medical announced this morning that CEO Gary Henley has resigned and SVP and CTO Frank Bono has been terminated, apparently over issues related to the company's compliance program. Chairman of the Board David Stevens has been named interim President and CEO. more

Align to Buy Cadent for $190M BY LAUREN UZDIENSKI, APRIL 4, 2011

Align Technology, the manufacturer of Invisalign, announced last week that they would purchase intra-oral scanner company Cadent for $190 million. Cadent offers 3-D scanning solutions and is a leader in the scanner space, which the press release says is growing... more

Alphatec Spine Receives 510(k) Clearance for Its Solus Anterior Lumbar Interbody Fusion System BY EDITOR, APRIL 4, 2011

Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced today that the Company has received 510(k) clearance from the FDA for its Solus Anterior Lumbar Interbody Fusion (ALIF) system. more


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