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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...

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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). 

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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...

Medtronic Completes $200M Deal for Cardiocom

August 13, 2013 10:02 am | by The Associated Press | News | Comments

Medtronic Inc. said Monday that it closed its $200 million acquisition of Cardiocom, which develops and provides services that help manage chronic diseases. The Minneapolis-based medical device maker said it doesn't expect the deal to affect its fiscal year 2014 profit.

CAS Medical wins a legal round against Covidien's Nellcor

August 12, 2013 11:31 am | by Mass Device | News | Comments

CAS Medical (NSDQ:CASM) won a round in a legal battle with Covidien's (NYSE:COV) Nellcor patient monitoring subsidiary over technology used to measure oxygen levels in the brain, after a federal judge in Michigan tossed a breach-of-contract claim against CasMed.

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Deep Brain Stimulation System Is First to Sense and Record Brain Activity While Delivering Therapy

August 12, 2013 11:27 am | by Medtronic | News | Comments

Medtronic, Inc. has announced the first implant of a novel deep brain stimulation (DBS) system that, for the first time, enables the sensing and recording of select brain activity while simultaneously providing targeted DBS therapy. This initiates research on how the brain responds to the therapy...

New Implantable Device Can Manipulate and Record Brain Activity

August 9, 2013 3:00 pm | by Massachusetts Institute of Technology | News | Comments

A new brain implant that can record neural activity while it simultaneously delivers electric current has been implanted into a patient for the first time. The new device from Medtronic, a Minneapolis-based medical device company, can also adjust its electrical output in response to the changing conditions of the brain.

Johnson & Johnson can exclude recall evidence in DePuy ASR bellwether lawsuit

August 9, 2013 1:13 pm | by Mass Device | News | Comments

Evidence of the recall of the DePuy ASR metal-on-metal hip implant can be excluded from a bellwether trial over the device, a federal judge ruled last month. Johnson & Johnson's DePuy Orthopaedics division pulled the DePuy ASR device from the market in 2010, prompting thousands of personal injury lawsuits across the country.

Boston Scientific prices $1B debt offering

August 9, 2013 11:37 am | by Mass Device | News | Comments

Boston Scientific said it plans to use the proceeds of a $1.05 billion debt offering to retire some of its other debt coming due over the next few years. The Natick, Mass.-based medical device company said it will offer $600 million worth of 2.65% senior notes due Oct. 1, 2018, and another $450 million worth of 4.125% notes due Oct. 1, 2023.

Zimmer owes Stryker $210M for willful infringement

August 8, 2013 1:31 pm | by Mass Device | News | Comments

Zimmer is on the hook for more than $210 million in damages owed to rival Stryker, after a federal judge in Michigan tripled a jury's $70 million decision. Kalamazoo, Mich.-based Stryker sued orthopedics rival Zimmer in December 2010, alleging infringement of 3 patents covering wound debridement technology with Zimmer's Pulsavac Plus device.

Conflicting decisions and new tactics in Medtronic Infuse lawsuits

August 8, 2013 1:06 pm | by Mass Device | News | Comments

The battle over Medtronic's Infuse bone-growth protein continues to be a roller-coaster, with judges in 2 states issuing seemingly conflicting rulings about the validity of patient injury lawsuits against the Minnesota medical device giant and its troubled Infuse bone-growth protein.

Cordis recall of Optease vena cava filter is Class I

August 8, 2013 12:01 pm | by Mass Device | News | Comments

The recall last March of Johnson & Johnson unit Cordis Corp.'s Optease vena cava filter is Class I, according to the FDA, meaning the device could cause serious injury or death. Cordis notified healthcare providers March 29 about 33,000 Optease devices, on concerns that they could be implanted backwards, according to the FDA.

GE, University of Washington to Develop 'Diagnostics-on-Demand' Device

August 8, 2013 9:00 am | by Business Wire | News | Comments

You’ve heard of on-demand TV, now imagine on-demand medical diagnosis – anytime, anywhere in the world. Scientists at GE Global Research are working with a team based at the University of Washington to develop a new medical device, the size of a pack of playing cards, that can detect infectious disease by way of a simple nasal swab, in less than an hour.

Stryker Interventional Spine Launches Two New Products to Expanding Portfolio

August 7, 2013 12:15 pm | by PRNewswire | News | Comments

Stryker Interventional Spine announced the clearance of 510(k)s for two additional products to its portfolio. Venom RF Cannula and Venom Electrode are designed to provide an effective and minimally invasive treatment for facet joint pain. The launch of the 11g iVAS Balloon System addresses the surgical trend of shifting toward less invasive treatment options.

Labeling glitch with Boston Scientific's Promus Element Plus prompts recall in Australia

August 7, 2013 12:01 pm | by Mass Device | News | Comments

Boston Scientific shipped some of its Promus Element Plus Monorail coronary stents with the wrong labels in Australia, prompting that country's Therapeutic Goods Administration to issue a recall. The Promus stents were shipped with incorrect directions for use Down Under, according to a TGA release.

Philips Announces FDA Clearance for Its Pinnacle³ Proton Treatment Planning System

August 7, 2013 11:02 am | by Philips | News | Comments

Royal Philips today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Pinnacle³ Proton treatment planning system in the U.S. Philips’ Pinnacle³ is a recognized treatment planning system for external beam radiotherapy, which provides accuracy and reliability to users independent of the treatment delivery system.

New Siemens CEO: 'Company is most definitely not in a crisis'

August 6, 2013 12:52 pm | by Mass Device | News | Comments

Newly appointed Siemens CEO Joe Kaeser is bullish about the company's prospects, calling Siemens "virtually unbeatable" – as long as it retains the right people. Kaeser, Siemens' former CFO who took over the corner office just last week, said in a recent shareholders letter that his top priorities at the moment are "to steer Siemens back into calm waters and build a powerful team."

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