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Orthopedic and Dental Industry News

October 2011

Dental News Roundup October 2011 BY MATTHEW JAFFE, OCTOBER 31, 2011

Earnings Dentsply reported that 3Q:11 sales increased 14.4% to $619.8 million, beating estimates by $29.2 million. Excluding precious metals, sales were $563.8 million compared to $494.3 million in 3Q:10, a 14.0% increase. EPS was $0.42, down 4.5% from $0.44 in... more

Musculoskeletal News Roundup 27-Oct-11 BY LAUREN UZDIENSKI, OCTOBER 27, 2011

Earnings CONMED reported 3Q:11 sales of $172.8 million, down 2% over the year-ago period and missing estimates by $6.8 million. Arthroscopy scales decreased by 1% to $69.4 million. Growth rates exclude the effects of currency. Non-GAAP diluted earnings per share... more

Post-DOJ Settlement, Researchers Note Changes in Payment Patterns BY LAUREN UZDIENSKI, OCTOBER 26, 2011

A news study published in the Archives of Internal Medicine sought to analyze changes in payments to orthopedic surgeons following five orthopedic manufacturers' 2007 settlement with the DOJ. What they found between 2007 and today was a decrease in the number of surgeons paid, an increase in the absolute dollar value of payments and a "need for clearer specific requirements for disclosure" from surgeons, companies and institutions. more

ACL and Meniscus Tears in Kids "Increased Dramatically" Over the Past Decade BY LAUREN UZDIENSKI, OCTOBER 24, 2011

Orthopedic surgeons from the Children's Hospital of Philadelphia presented data about pediatric knee injuries at this week's American Academy of Pediatrics annual meeting, and the results demonstrated new trends in sports medicine: pediatric ACL and meniscal tears have "increased dramatically" over the prior twelve years. Notably, tibial spine fractures, or the bone where the ACL attaches, remained flat over the same time period, indicating a shift in injury patterns. more

News and Trends at Eurospine BY LAUREN UZDIENSKI, OCTOBER 21, 2011

This week we attended Eurospine in Milan, and we came away noticing a couple of trends. One, VCF technologies are continuing to generate a lot of interest, despite the damper the NEJM studies may have placed on these products in the U.S. Also notable was the increasing prominence of companies based in Asia, who may be playing more of a role in the EU market as cost containment and austerity measures affect hospital budgets. Finally, we observed U.S. companies using Eurospine as an opportunity to highlight their increasing international reach. more

Musculoskeletal News Roundup 20-Oct-11 BY LAUREN UZDIENSKI, OCTOBER 20, 2011

KNSY, JNJ, Medicrea, SYK, SYST announce 3Q . . . BMTI receives Australian approval for Augment . . . FDA clears Medtronic's Aquamantys3 System . . . K2M launches RAVINE Lateral Access System . . . Medicrea highlights six products at Eurospine . . . Globus to fund MIS spine outcomes registry . . . Zimmer to distribute Benvenue's Kiva . . . Lanx creates Surgeon Advisory Board more

TranS1 Subpoenaed by OIG BY LAUREN UZDIENSKI, OCTOBER 18, 2011

TranS1 announced yesterday that the company received a subpoena from the OIG relating to federal healthcare fraud and false claims statutes. The document was received on or around October 6th. more

Senate Bill Would Streamline FDA Process BY LAUREN UZDIENSKI, OCTOBER 17, 2011

Senators Amy Klobuchar (D-MN), Richard Burr (R-NC) and Michael Bennet (D-CO) have introduced new legislation that would relax the conflict-of-interest rules around FDA panels and mandate that the FDA use "all reasonable mechanisms to reduce review times". more

House Democrats Request Hearings on Metal-on-Metal BY LAUREN UZDIENSKI, OCTOBER 13, 2011

Democrats from the House Energy and Commerce Committee have asked Republican leaders to hold hearings on metal-on-metal hips and brain stents. In a letter, Democrats said these devices have caused "significant harm to human health". Bloomberg writes that the FDA has received more than 5,000 complaints about metal-on-metal hips, among about 500,000 patients who have received the devices; the backlash from the ASR alone is already expected to cost DePuy over $1 billion. more

Musculoskeletal News Roundup 13-Oct-11 BY LAUREN UZDIENSKI, OCTOBER 13, 2011

aap Implantate pre-announces 3Q:11 ... ISTO receives CE mark for InQu ... Biomet celebrates 35th anniversary of the Oxford partial knee ... TiGenix announces Finnish distribution for ChondroCelect more

The Latest Developments for MDUFA III BY LAUREN UZDIENSKI, OCTOBER 12, 2011

The back-and-forth between industry and the FDA continues over the re-authorization of MDUFA, which grants industry user fees to the FDA. In the latest set of minutes from the ongoing negotiations, stakeholders address proposed changes to the process and how to achieve goals like shorter review times and a more transparent, predictable path to market. more

FDA, CMS Launch Joint Review Pilot BY LAUREN UZDIENSKI, OCTOBER 11, 2011

"Safe and effective" and "reasonable and necessary" will align in a new pilot program from the FDA and CMS. The two agencies will test the joint review of medical devices, enabling Medicare reimbursement coverage to coincide with market approval. Historically,... more

Hawkins to Lead Immucor, Inc. BY LAUREN UZDIENSKI, OCTOBER 6, 2011

Former Medtronic CEO Bill Hawkins will be Immucor's new CEO, taking the reins from Joshua Levine, who is stepping down to spend more time with family. The appointment will be effective October 17, 2011. more

Musculoskeletal News Roundup 6-Oct-11 BY LAUREN UZDIENSKI, OCTOBER 6, 2011

Biomet announces earnings . . . OrthoPediatrics raises $20M . . . OsteoGeneX spins off OssiFi . . . Vexim prepares to launch SpineJack in India . . . IART launches new spine products . . . Ranier Technology inks distribution deal for Germany and Switzerland . . . OFIX promotes Bryan McMillan President of the Spine Global Business Unit more

MDT's Ishrak: U.S. Should "Absolutely" Adopt EU Regulatory System BY LAUREN UZDIENSKI, OCTOBER 5, 2011

In comments to the Financial Times, Medtronic CEO Omar Ishrak criticized the FDA for a slow regulatory process that limits patient access to care. In the EU, "the response time is quicker, the clinical trial cycle is quicker, and maybe some of the barriers are less stringent," Mr Ishrak told the FT. He also spoke in favor of adopting a regulatory process more like the Europe's, adding, "It will certainly put products on the market more quickly, so from a very selfish device manufacturer perspective, absolutely." more

FDA Touts Advances in Regulatory Science BY LAUREN UZDIENSKI, OCTOBER 3, 2011

CDRH released a report yesterday highlighting the agency's activities in the field of regulatory science, efforts they say aid device manufacturers in product development and accelerate market approvals. more


Complete Archive