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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

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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...

Electrochem Announces Patent Award For Battery Support System

November 20, 2012 9:00 am | by The Associated Press | News | Comments

CLARENCE, N.Y.--(BUSINESS WIRE)--Nov 20, 2012--Electrochem Solutions, Inc. (Electrochem), a subsidiary of Greatbatch, Inc. (NYSE:GB) today announced an award for U.S. Patent No. 8,252,441 - Spacers for Fixing Battery Cells Within a Battery Package Casing and Associated Systems and Methods (File...

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Stryker exec charged in $1.7M insider trading scheme | MassDevice.com On Call

November 20, 2012 8:29 am | by Mass Device | News | Comments

The Securities & Exchange Commission charges Stryker marketing executive Mark Foldy alongside a handful of others in an insider trading scheme that allegedly generated $1.7 million in illegal profits and kickbacks. MASSDEVICE ON CALL — Former Stryker (NYSE:SYK) marketing executive Mark Foldy was charged alongside a handful of others for his alleged participation in an insider trading scheme that federal authorities say generated $1.7 million in illegal profits and kickbacks. Legal News, News Well, Insider Trading, On Callread more

Medtronic Reports Second Quarter Earnings

November 20, 2012 7:18 am | by The Associated Press | News | Comments

Revenue of $4.1 Billion Grew 5% on a Constant Currency Basis; 2% as Reported International Revenue Grew 8% on a Constant Currency Basis; 1% as Reported Company Updates FY13...

Thermo Fisher licenses sepsis test to Japanese firm

November 20, 2012 12:00 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Thermo Fisher Scientific Inc.(NYSE: TMO) has signed a long-term license agreement with Japanese firm Fujirebio Inc. to make its test for the early detection of sepsis available on the Japanese firms laboratory instruments.

Victims of meningitis outbreak file petition in Mass. court

November 20, 2012 12:00 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Several law firms, including Brown Rudnick LLP and Andrews & Thorton, have filed a petition in Massachusetts state court to appoint a receiver in the case against New England Compounding Center, the Framingham pharmacy at the center of the deadly fungal meningitis outbreak.

Pot-dispensing machine maker explains stock highs

November 20, 2012 12:00 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Medbox Inc. (OTC:MDBX), a California-based company with offices in Connecticut, which has developed a drug dispensing system that uses hardware, software and biometric scans to verify a medical marijuana patient’s identity has using both the person’s ID card and a biometric fingerprint scan, has seen its stock jump to record highs recently.

medInt and Nuance Offers Integrated Workflow Solution to be showcased at the Nuance Partner Pavilion at RSNA 2012

November 19, 2012 7:07 pm | by The Associated Press | News | Comments

medInt Holdings, LLC, a Healthcare IT company offering enterprise-wide imaging solutions, and Nuance Communications, Inc. today announced the integration of their respective technologies to provide radiation dose information to radiologists. The collaboration between these organizations comes...

NuVasive Management to Participate in Investor Events in November and December 2012

November 19, 2012 4:30 pm | 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 management will participate in the following investor events in November and December 2012: ...

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