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FDA OKs HeartWare device for transplant patients

November 20, 2012 3:13 pm | by The Associated Press | News | Comments

The Food and Drug Administration on Tuesday approved a new heart pump for patients with severe heart failure who are awaiting a heart transplant. Regulators approved HeartWare's Ventricular Assist System, a battery-powered device that is implanted in the chest, where it helps the heart's lower...

HeartWare Receives FDA Approval for HeartWare@ Ventricular Assist System as a Bridge to Heart Transplantation for Patients with Advanced Heart Failure

November 20, 2012 2:43 pm | by The Associated Press | News | Comments

HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that it has received approval from the United States Food and Drug...

Breaking: HeartWare wins FDA nod for bridge-to-transplant heart pump

November 20, 2012 2:35 pm | by Mass Device | News | Comments

HeartWare wins premarket approval for its flagship implantable left ventricular assist device as a bridge to transplant for heart failure patients. Framingham, Mass.-based cardiac device maker HeartWare International (NSDQ:HTWR) won FDA premarket approval for its HeartWare ventricular assist system as a bridge to heart transplantation The HeartWare system includes an implantable pump, external driver and power source that can be used either inside or outside of hospitals, the FDA noted. News Well, Cardiac Assist Devices, Cardiac Implants, Food & Drug Administration (FDA), Pre-Market Approval (PMA)read more

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Cutting-Edge German Medical Innovations Put Patients First

November 20, 2012 2:32 pm | by Bio-Medicine.Org | News | Comments

CHICAGO, Nov. 20, 2012 /- Germany is a world leader in medical technology and can claim – depending on topic – between 5 and 20 percent of published research in the field. Germany's Federal Ministry of Education and Research (BMBF) is bringing the show on the road, presenting the latest research from about three dozen German innovators at the Radiological Society of...

Medical Device Market Updates: IVD and Ophthalmic Devices Dominate China's $30.5 bn Medical Device Market; Invisible Hearing Aids Set to Make Big Noise

November 20, 2012 2:03 pm | by Bio-Medicine.Org | News | Comments

FARMINGTON, Conn., Nov. 20, 2012 /PRNewswire-iReach/ -- Big innovations are emerging in the global market for medical devices. New market research forecasts medical devices in China to reach $30.4 billion by 2018, while the global market for hearing aid devices is expected to hit $11.3 billion in that same time, and surgical equipment is currently on pace to reach $7 billion. (Photo: http://p...

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Alpha Imaging Acquires Clinical Applications Training Company

November 20, 2012 1:51 pm | by Bio-Medicine.Org | News | Comments

CLEVELAND, Nov. 20, 2012 /PRNewswire-iReach/ -- Alpha Imaging LLC, a leading distributor of advanced medical imaging equipment based in Cleveland, Ohio, today announced they have acquired Chesapeake Applications Inc., a Pennsylvania-based company, to enhance their clinical applications training portfolio.  Chesapeake Applications provides clinical training on Shimadzu Medical Systems, Canon...

In-Kind Donations Make Knee Replacement Possible for Patients in Rural Mexico

November 20, 2012 1:34 pm | by The Associated Press | News | Comments

GAINESVILLE, Fla.--(BUSINESS WIRE)--Nov 20, 2012--At a time many Americans devote to counting their blessings, a group of underprivileged patients in Veracruz, Mexico are thankful to be regaining the most critical aspects of rural life – their mobility and livelihood. In a hospital with a limited...

Stryker on track for 1,000 layoffs ahead of medtech tax

November 20, 2012 11:59 am | by Mass Device | News | Comments

Stryker is on track for the 5% workforce reduction that the company said it would conduct before the end of this year in anticipation of a $150 million tab for compliance with the medical device tax taking effect January 1. Orthopedic giant Stryker is on track with the previously announced layoffs that the company blamed on the 2.3% medical device tax slated to take effect in January. The layoffs, which Stryker announced around this time last year, are being conducted on a rolling basis and the company expects to free up more than $100 million in costs before next year. News Well, Layoffs, Medical Device Tax, Orthopedicsread more

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FDA slaps HeartSine with Class I recall

November 20, 2012 10:45 am | by Mass Device | News | Comments

HeartSine's recall of Samaritan defibrillators gets Class I status from the FDA over concerns that battery defects could lead to patient injury or death. The FDA gave HeartSine's Samaritan defibrillator recall Class I status over concerns that battery issues could lead to patient injury or death. The Samaritan 300/300P public access defibrillators, which were found to intermittently turn off and on, may be unable to deliver therapy during a cardiac event due to the battery defects. News Well, Cardiac Assist Devices, Food & Drug Administration (FDA), Recallsread more

FluoroPharma Medical, Inc. Announces $1.5M Equity Financing

November 20, 2012 10:15 am | by The Associated Press | News | Comments

FluoroPharma Medical, Inc. (OTCQB: FPMI), a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today announced that it completed a...

FDA's new unique device ID timing cuts deadlines for some device labels by 5 years

November 20, 2012 10:15 am | by Mass Device | News | Comments

New unique device identifier deadlines required by a law signed earlier this year force the FDA to shorten some of its labeling timeframes by as much as 5 years. The FDA's UDI label example: Product name, expiration date, reference and lot nos., manufacturer information, barcode, details and illustration. The FDA issued new timelines for its long-awaiting "unique device identifier" system for tracking and monitoring medical technology, cutting short some deadlines for implementation by as much as 5 years in order to comply with a new law. News Well, Food & Drug Administration (FDA), Regulatory/Complianceread more

LifeMap Sciences, a Subsidiary of BioTime, Signs Definitive Distribution Agreement with ProSpec-Tany TechnoGene

November 20, 2012 9:58 am | by The Associated Press | News | Comments

ALAMEDA, Calif.--(BUSINESS WIRE)--Nov 20, 2012--LifeMap Sciences, Inc. a subsidiary of BioTime, Inc. (NYSE MKT: BTX) announced today that it has signed a definitive distribution agreement with ProSpec-Tany TechnoGene Ltd. (ProSpec). In the beginning of 2013, LifeMap Sciences will be offering more...

Smith & Nephew names new CFO | Personnel Moves

November 20, 2012 9:45 am | by Mass Device | News | Comments

Smith & Nephew welcomes Julie Brown as CFO after former CFO Adrian Hennah stepped down from his position in September.  Smith & Nephew names Julie Brown its new finance chief News Well, Personnel, Personnel Movesread more

Medtronic meets The Street despite 25% earnings slide, raises sales outlook

November 20, 2012 9:26 am | by Mass Device | News | Comments

Medtronic's fiscal 2nd-quarter results meet Wall Street's expectations despite a more than 25% decline in profits. UPDATED Nov. 20, 9:30 a.m. with details on business segment results. Medtronic (NYSE:MDT) managed to meet Wall Street's profit expectations despite a $245 million charge to cover "certain litigation" in its structural heart business that pushed earnings down more than 25%. News Well, 2012, MassDevice Earnings Roundup, Q3read more

Verastem’s Screening Technology Highlighted in New Study in the Journal of Biomolecular Screening that Identifies Novel Chemicals Targeting Cancer Stem Cells

November 20, 2012 9:20 am | by The Associated Press | News | Comments

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 20, 2012--Verastem, Inc., (NASDAQ: VSTM) a clinical-stage biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, announced that researchers at the Broad Institute have published a...

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