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Two-Year Clinical Study Supports Safety and Efficacy of Covidien Solitaire™ FR Revascularization Device

February 7, 2013 6:42 pm | by The Associated Press | News | Comments

MANSFIELD, Mass.--(BUSINESS WIRE)--Feb 7, 2013--Covidien (NYSE:COV), a leading global provider of healthcare products, today released the results of the Solitaire™ FR Thrombectomy for Acute Revascularization (STAR) study. The two-year study evaluated the safety and efficacy of the Solitaire FR...

Two-Year Clinical Study Supports Safety and Efficacy of Covidien Revascularization Device

February 7, 2013 6:42 pm | by The Associated Press | News | Comments

MANSFIELD, Mass.--(BUSINESS WIRE)--Feb 7, 2013--Covidien (NYSE:COV), a leading global provider of healthcare products, today released the results of the Solitaire™ FR Thrombectomy for Acute Revascularization (STAR) study. The two-year study evaluated the safety and efficacy of the Solitaire FR...

Senate Follows House in Launching Medical Device Tax Repeal Bill

February 7, 2013 6:01 pm | by Mass Device | News | Comments

Lawmakers deliver a 1-2-punch in launching parallel medical device tax repeal bills in the House of Representatives and then the Senate just a day apart. A bipartisan group of Senators today released a bill that would repeal the 2.3% medical device tax, closely following a parallel bill released in the House of Representatives yesterday.

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Judge Stays C.R. Bard Suit Against Hologic over Mammosite Device

February 7, 2013 4:50 pm | by Mass Device | News | Comments

A federal judge stays a patent infringement lawsuit filed by C.R. Bard subsidiary SenoRx over Hologic's Mammosite device for treating breast cancer. A federal judge in Delaware put a patent infringement spat between C.R. Bard subsidiary SenoRx and Hologic (NSDQ:HOLX) on hold for 90 days last week.

American Association for Cancer Research to Host Congressional Briefing About Progress in Cancer Research

February 7, 2013 4:50 pm | by AACR | News | Comments

Deputy Director of the National Cancer Institute, Dr. Douglas Lowy, will address the audience. Event will showcase the AACR Cancer Progress Report, which is a call to action to make funding for the National Institutes of Health a national priority. A foremost expert in blood cancers will describe progress in multiple myeloma.

CareFusion Reports First Half Fiscal 2013 Results

February 7, 2013 4:03 pm | by The Associated Press | News | Comments

CareFusion Corp. (NYSE: CFN), a leading, global medical technology company, today reported results for the three and six months ended Dec. 31, 2012. "Our consolidated first and second quarter financial results were led by strong performance across the Procedural Solutions segment, where each...

Diabetes: Insulet and Dexcom Call It Quits on Development Agreement

February 7, 2013 3:34 pm | by Mass Device | News | Comments

Insulet and Dexcom decide not to pursue a joint development agreement to integrate Dexcom's continuous glucose monitoring technology with Insulet's insulin-infusing OmniPod. Diabetes technology makers Insulet and Dexcom Inc. abandoned a 5-year-old joint development deal that would have merged Dexcom's continuous glucose monitoring technology with Insulet's OmniPod insulin delivery system.

Researchers Find a Genetic Marker for Aortic Valve Disease

February 7, 2013 2:13 pm | by Mass Device | News | Comments

A research consortium tracks down a genetic variant that doubles the risk of buildup in the aortic valve that can cause heart failure, stroke and sudden cardiac death. A team of researchers have pinpointed a gene that may be responsible for double a patient's risk of calcium buildup in the aortic valve, a condition linked with heart failure, stroke and sudden cardiac death. The finding may lead to new research and therapies, which are very limited for patients with narrowing, or stenosis, of the aortic valve.

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Losses Soar, Shares Plummet for Accuray

February 7, 2013 2:09 pm | by Mass Device | News | Comments

Accuray's fiscal 2nd quarter sales plunge and its losses gape wider, sending share prices down almost 10% today. Accuray (NSDQ:ARAY) shares lost nearly 10% today after the medical device company reported soaring losses and a nearly 27% sales slide for its fiscal 2nd quarter. The Sunnyvale, Calif.-based company, which makes radiation oncology equipment, posted losses of $29.2 million, or 40¢ per share, on sales of $77.8 million for the 3 months ended Dec. 31, 2012.

Fully Automatic AED Plus from ZOLL Granted 510(k) Clearance by U.S. Food and Drug Administration

February 7, 2013 1:22 pm | by The Associated Press | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--Feb 7, 2013--ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market and begin U.S. distribution of the new fully...

CT Scanner Delivers Less Radiation

February 7, 2013 12:33 pm | by Massachusetts Institute of Technology | News | Comments

Faster, more sensitive scans and better image processing may reduce the risk of x-ray-related cancers. A new CT scanner exposes patients to less radiation while providing doctors with clearer images to help with diagnoses, according to researchers at the National Institutes of Health.

Sorin Group Announces Preliminary Results for 2012

February 7, 2013 12:06 pm | by The Associated Press | News | Comments

MILAN--(BUSINESS WIRE)--Feb 7, 2013--At a meeting held today and chaired by Rosario Bifulco, the Sorin S.p.A. (MIL:SRN) Board of Directors analyzed the results for the fourth quarter 2012 and the preliminary unaudited consolidated results for the year of 2012. The final draft of the financial...

Effective Drug-free Treatment for Migraine Published in NEUROLOGY

February 7, 2013 10:34 am | by PR Newswire | News | Comments

LIEGE, Belgium, February 7, 2013 /PRNewswire/ -- The American scientific journal NEUROLOGY publishes the positive results of the PREMICE clinical study on the effectiveness and safety of the CEFALY® medical device in the prevention of migraine. NEUROLOGY (official journal of the...

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Biosensors Collaborates with Terumo to Promote NoboriT in Japan

February 7, 2013 10:05 am | by The Associated Press | News | Comments

Biosensors International Group, Ltd., a developer, manufacturer and marketer of innovative medical devices, has announced a collaboration with Terumo Corporation to promote the NoboriT drug-eluting stent (DES) system at specific specialist cardiology centers in Japan.

Cardiva Medical, Inc. Announces FDA Approval for VASCADE Vascular Closure System

February 7, 2013 9:40 am | by PRNewswire | News | Comments

Cardiva Medical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for the VASCADE Vascular Closure System (VCS). Clinical data from a prospective, multi-center, randomized 420 patient trial demonstrated that the VASCADE VCS is clinically and statistically superior in both safety and efficacy compared to manual compression...

Banner MD Anderson Cancer Center Acquires Multiple Elekta Cancer Management Systems

February 7, 2013 9:00 am | by PR Newswire | News | Comments

GILBERT, Ariz., Feb. 7, 2013 /PRNewswire/ -- Banner MD Anderson Cancer Center (Gilbert, Arizona, USA) recently acquired Elekta cancer management solutions, including two Elekta Infinity™ radiation therapy systems, each with an Agility™* 160-leaf multileaf collimator (MLC)...

Basketball Hall-of-Famer, Bill Walton, Tours the Nation to Speak About Life-Changing Spine Surgery

February 7, 2013 8:30 am | by The Associated Press | News | Comments

NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that Bill Walton, Basketball Hall-of-Famer and a Better Way Back® patient ambassador, has successfully completed a nationwide tour...

ERBA Diagnostics, Inc. Appoints Mohan Gopalkrishnan V.P. Operations

February 7, 2013 8:20 am | by The Associated Press | News | Comments

MIAMI--(BUSINESS WIRE)--Feb 7, 2013--ERBA Diagnostics, Inc. (NYSE MKT: ERB), a fully integrated in vitro diagnostics company, has appointed Mohan Gopalkrishnan as Vice President - Operations. Mr. Gopalkrishnan will be responsible for managing ERBA Diagnostics’ daily operations and will be based in...

Affymetrix and DNA Link Sign Partnership for Forensic Test Development for Human Identification

February 7, 2013 6:30 am | by The Associated Press | News | Comments

SANTA CLARA, Calif.--(BUSINESS WIRE)--Feb 7, 2013--Affymetrix, Inc. (NASDAQ: AFFX) and DNA Link, Inc., a Korean genomics-based biotechnology company, today announced that they have signed a Powered by Affymetrix TM (PbA) Program agreement in which DNA Link, Inc. obtains a worldwide license to...

Palomar Medical Reports Financial Results for Fourth Quarter and Fiscal Year 2012

February 7, 2013 4:07 am | by GlobeNewswire | News | Comments

BURLINGTON, Mass., Feb. 7, 2013 (GLOBE NEWSWIRE) -- Palomar Medical Technologies, Inc. (Nasdaq:PMTI), a global leader in laser and other light-based systems for aesthetic treatments, today announced financial results for the fourth quarter and year ended December 31, 2012.

Class I Medical Device Recall: Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower

February 7, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

During ventilation of small pediatric patients with high airway resistance and low lung function, there may be unexpected high internal oxygen consumption by HAMILTON-T1 ventilators with software versions 1.1.2 and lower.

Abiomed CEO Shrugs off Impact of DoJ Probe, FDA Call

February 6, 2013 4:41 pm | by Mass Device | News | Comments

A U.S. Justice Dept. investigation and the FDA's decision to require pre-market approval for Abiomed's Impella heart pump leave CEO Michael Minogue unfazed. Cardiologists aren't paying much attention to the noise around Abiomed (NSDQ:ABMD) and its flagship medical device, the Impella heart pump, at least according to chairman, president & CEO Michael Minogue.

Medifocus Inc. Announces Launch of New Website

February 6, 2013 12:48 pm | by The Associated Press | News | Comments

Medifocus, Inc. (OTCQX: MDFZF), (TSX VENTURE: MFS) (Medifocus or the Company), a commercial stage, revenue producing biotechnology company focused on the use of focused microwave for the development and commercialization of minimally invasive systems for the treatment of cancerous and benign...

Cancer: Guided Therapeutics, Konica Minolta in esophageal cancer pact

February 6, 2013 12:37 pm | by Mass Device | News | Comments

Guided Therapeutics will take development of its esophageal cancer detection device in-house under the terms of new deal with Konica Minolta. Guided Therapeutics (OTC:GTHP) and its largest customer, Konica Minolta (TYO:4902), agreed to alter a development deal for an esophageal cancer detection device.

Medical device tax: Paulsen re-boots repeal bid with new bill, Senate measure to follow

February 6, 2013 12:33 pm | by Mass Device | News | Comments

Reps. Erik Paulsen and (R-Minn.) and Ron Kind (D-Wis.) introduce a bill to repeal the medical device tax, with a companion bill expected to follow in the Senate. Rep. Erik Paulsen (R-Minn.) filed a new bill aimed at repealing the 2.3% medical device excise tax today, following up on his commitment to do away with the levy.

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