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Biomet’s revised earnings show much wider losses than previously reported

September 3, 2013 8:59 am | by Mass Device | News | Comments

Biomet amended its Q4 and annual earnings report to reflect a swing to red in Q4 and much deeper losses for the full year compared to earlier reports. The Warsaw, Ind.-based orthopedics company posted losses of $221.2 million on $784 million in sales during the 3-month period ended May 31, 2013.

Medtronic Announces Formation of Hospital Solutions Business Aimed at Driving Efficiencies and Cost Savings

September 2, 2013 12:06 pm | by The Associated Press | News | Comments

Medtronic, Inc. (NYSE: MDT) today announced the formation of Medtronic Hospital Solutions, a new business focused on developing novel partnerships with hospitals to provide services directly related to hospital operational efficiency. The new business will focus initially on offering services in Europe...

Class I Recall Strikes Stryker Spine

August 29, 2013 12:59 pm | by David Mantey, Executive Editor, MDT | News | Comments

The U.S. Food and Drug Administration (FDA) hit Allendale, NJ-based Stryker’s Spine division with a Class I recall for the company’s OASYS Midline Occiput Plate. According to reports, Stryker learned that a post-operative fracture can occur in the pin that connects ...

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St. Jude’s New Renal Denervation System Reduces Total Ablation Time by More Than 80%

August 29, 2013 10:51 am | by Business Wire | News | Comments

St. Jude Medical, Inc., a global medical device company, today announced the CE Mark approval of its next-generation EnligHTN Renal Denervation System for treating patients with drug-resistant, uncontrolled hypertension. The system features an advanced generator that delivers simultaneous ablations via a multi-electrode catheter...

Medtronic's maneuvers may signal long-term struggles for industry

August 28, 2013 12:51 pm | by Mass Device | News | Comments

When Medtronic announced that it paid $200 million in cash for chronic disease management firm Cardiocom the medical device giant said the acquisition was indicative of a broader vision for the company's future, but Wall Street analysts are warning that it may also suggest "challenging times ahead" for the device industry.

Biomet's preemption bid fails, company proceeds to trial over metal hips

August 28, 2013 12:29 pm | by Mass Device | News | Comments

Biomet will go to bat over its M2A-magnum metal-on-metal hip implants after failing to convince an Indiana federal judge that a personal injury lawsuit was preempted by FDA rules. The plaintiff, Leslie Caccia, sued Biomet for a supposedly defective metal-on-metal hip implant in what is now part of a larger multi-district litigation.

Medinol goes after J&J's Cordis in stent patent war

August 28, 2013 9:29 am | by Mass Device | News | Comments

Cordis Corp., the stent-making arm of Johnson & Johnson, got out of the coronary stent game 2 years go, but that's not stopping Israeli medical device company Medinol from suing Cordis for patent infringement with the Cypher and Cypher Select stents it no longer makes.

South Korea is a "key market" in Covidien's global strategy

August 27, 2013 1:36 pm | by Mass Device | News | Comments

Massachusetts medical device maker Covidien is opening the doors on a new Center of Innovation in South Korea, a country that the company calls "a key market in our global strategy." Covidien plans to spend $21 million over the course of 3 years to support the center...

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Medtronic hands Pioneer Plus catheters to Volcano in closed-doors deal

August 27, 2013 12:40 pm | by Mass Device | News | Comments

Medical device giant Medtronic is handing its Pioneer Plus re-entry catheter product line over to Volcano for an undisclosed amount, the companies announced this week. The deal, which Volcano hopes will help it expand its reach in peripheral indications, is expected to close this month and is structured as an "asset purchase."

Biomet units lose $2.7M royalty dispute with spine surgeon

August 27, 2013 9:29 am | by Mass Device | News | Comments

Two Biomet subsidiaries are on the hook for some $2.7 million in royalty payments to a prominent spine surgeon it stopped paying in 2008, after a New Jersey appeals court upheld a lower court's ruling in Dr. Neil Kahanovitz's favor. Kahanovitz, the former president of the North American Spine Society, sued Biomet units Electro-Biology Inc. and EBI LLC...

Another lawsuit against Medtronic's Infuse proceeds in Arizona

August 27, 2013 8:59 am | by Mass Device | News | Comments

Another patient injury lawsuit is set to proceed against Medtronic and it's problematic Infuse bone-growth protein after an Arizona district judge ruled that federal preemption doesn't apply in a case accusing the company of off-label marketing, a relatively new tactic that is proving somewhat successful for patients waging battles against medical device makers.

Covidien Opens US$21 Million Research & Development and Training & Education Center in South Korea

August 27, 2013 7:00 am | by Business Wire | News | Comments

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the opening of the Covidien Center of Innovation Korea (CCI Korea), its first research & development (R&D) and training & education center in Korea. With a total investment of US$21 million over a three year period, CCI Korea is a high-tech medical training center focused on raising awareness of various disease states...

Volcano Corporation Announces Execution Of Agreement To Purchase Pioneer PlusT Re-Entry Catheter Product Line From Medtronic

August 26, 2013 4:05 pm | by The Associated Press | News | Comments

Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, said today it has signed an agreement to acquire the Pioneer PlusT diagnostic ultrasound ...

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German ban on Medtronic TAVI begins today, Edwards makes room for 'compassionate cases'

August 26, 2013 3:50 pm | by Mass Device | News | Comments

Starting today, medical device giant Medtronic is banned from selling its CoreValve and CoreValve Evolut transcatheter aortic valve implantation systems in Germany, thanks to a court ruling in favor of rival device maker Edwards Lifesciences.  

BD Supports the FDA's Proposal to Reclassify Rapid Influenza Tests

August 26, 2013 9:32 am | by PR Newswire | News | Comments

BD, a leading global medical technology company, supports the U.S. Food and Drug Administration's (FDA's) proposed reclassification of rapid influenza detection tests. A hearing, held on June 13th by FDA's CDRH Microbiology Devices Advisory Committee Meeting, examined the FDA's proposal to reclassify rapid influenza detection tests (RIDTs) currently regulated as Class I devices, into Class II devices.

Fed Rejects Medtronic's Preemption Claim In Off-Label Use of Device

August 23, 2013 4:47 pm | by Business Wire | News | Comments

Kent L. Klaudt, lawyer at the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that U.S. District Court Judge G. Murray Snow of the District of Arizona denied in large part Medtronic’s motion to dismiss a personal injury lawsuit brought by Dr. Cristina Ramirez against the company on grounds that the claims are preempted by Federal law.

Smith & Nephew forges settlement in trade secrets lawsuit against staffing company

August 23, 2013 1:29 pm | by Mass Device | News | Comments

Healthcare giant Smith & Nephew (FTSE:SN, NYSE:SNN) came to terms with former staffing services provider Northwest Ortho Plus, putting to bed a year-old trade secrets dispute. The original lawsuit, which accused Northwest of damaging Smith's goodwill and compromising valuable corporate information, was seeking $56 million in damages...

Baxter appeases EU regulators in $4B Gambro buyout

August 22, 2013 12:51 pm | by Mass Device | News | Comments

After months of negotiations with EuroZone regulators, Baxter's (NYSE:BAX) nearly $4 billion buyout of Swedish dialysis maker Gambro AB can go forward now that Baxter agreed to sell off its renal replacement therapy division to ease anti-trust concerns.

Becton false advertising and antitrust lawsuit heads to trial

August 22, 2013 11:29 am | by Mass Device | News | Comments

Becton Dickinson & Co. (NYSE:BDX) is headed to court next month to speak to allegations, brought by rival Retractable Technologies' (NYSE:RVP), that it engaged in illegal in order to maintain a monopoly in the syringe business.  

Covidien recalls flush syringes

August 20, 2013 1:59 pm | by Mass Device | News | Comments

Covidien recalled some lots of its Monoject syringes after discovering a sterilization mishap and labeling problem. The issues affected 14 lots in shipments that went out to customers in the U.S. and Bermuda, the Mansfield, Mass.-based medical products giant said.

Medtronic dips on missed Q1 revenues

August 20, 2013 10:19 am | by Mass Device | News | Comments

Investors pushed shares of Medtronic down this morning after the world's largest pure-play medical device company reported mixed results for its fiscal 1st quarter. Fridley, Minn.-based Medtronic posted profits of $953 million, or 93¢ per share, on sales of $4.08 billion for the 3 months ended July 26.

Boston Scientific Completes Enrollment In SuperNOVA Trial Evaluating Innova™ Self-Expanding Stent System

August 19, 2013 6:02 pm | by PR Newswire | News | Comments

Boston Scientific Corporation (NYSE: BSX) has completed enrollment in the SuperNOVA trial – a global, single arm, prospective, multicenter trial evaluating the long-term (12 month) safety and effectiveness of the Innova™ Self-Expanding Stent System (Innova Stent System). 

Bard Announces Agreement to Acquire Medafor, Inc.

August 19, 2013 8:00 am | by Business Wire | News | Comments

C. R. Bard, Inc. has announced that it has entered into a definitive agreement to acquire privately-held Medafor, Inc., a leading developer and supplier of plant based hemostatic agents for the purchase price of $200 million paid at closing, expected to occur later this year, and future contingent payments up to an additional $80 million based on specific revenue-based milestones through June 30, 2015.

GPOs: Medtronic, St. Jude, Boston Scientific land new deals from Premier

August 13, 2013 12:27 pm | by Mass Device | News | Comments

Premier Healthcare Alliance awarded several new contracts for drug-eluting stents, traditional stents and other intervention products to 8 heavy hitters in the cardiology space. Abbott, Boston Scientific, and Medtronic all landed supplier deals for drug-eluting and traditional stents.

Anapol Schwartz Now Investigating DePuy Limb Preservation System Recall

August 13, 2013 11:24 am | by The Associated Press | News | Comments

The Anapol Schwartz national law firm is now investigating the Class I recall of the Limb Preservation System (LPS) Lower Extremity Dovetail Intercalary Component issued by DePuy Orthopaedics on July 11, 2013. Patients who have suffered a LPS failure are encouraged to contact the firm...

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