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Class II Medical Device Recall: Triad Group, Triad Sterile Lubricating Jelly

February 15, 2011 4:30 am | by U.S. Food & Drug Administration | Comments

Reason for Recall: This product may not be sterile. Patients, who are immuno-compromised, such as those with diabetes, cancer and certain other chronic diseases, may be at potential risk for infection.


Nfocus Neuromedical, Inc. Lunaâ„¢ Aneurysm Embolization System Receives CE Mark

February 15, 2011 2:34 am | by Bio-Medicine.Org | Comments

PALO ALTO, Calif., Feb. 15, 2011 /- Nfocus Neuromedical, Inc., an innovative medical device company with a focus on the next generation treatment for brain aneurysms, announced today that its Luna™ Aneurysm Embolization System (AES) received CE Mark for the treatment of patients...


Covidien to Launch TurboHawk(TM) Plaque Excision System for Small Vessels

February 15, 2011 2:33 am | by Covidien | Comments

New system offers greater efficiency and more consistent performance for physicians MANSFIELD, Mass., Feb 15, 2011 (BUSINESS WIRE) --Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that it will launch the TurboHawk(TM) Plaque Excision System for...


Orascom Telecom, Mobinil and Great Connection Collaborate to Launch Mobile Babyâ„¢ Service in Egypt

February 14, 2011 11:33 pm | by Bio-Medicine.Org | Comments

BARCELONA, Spain, Feb. 15, 2011 /- Orascom Telecom and Mobinil, in collaboration with Great Connection, today announced the launch of a pilot project to bring mobile DICOM sonar images remote diagnostics to pregnant women in Egypt.   Mobile Baby™ service, offered in Egypt by...


Updated heart disease prevention guidelines for women focus more on 'real-world' recommendations

February 14, 2011 8:36 pm | by EurekAlert | Comments

(American Heart Association) Updated cardiovascular prevention guidelines for women focus on what works best in the "real world" vs. clinical research settings and consider personal and socioeconomic factors that can keep women from following medical advice and treatment. The...


Axsun Technologies unveils data acquisition board for Optical Coherence Tomography systems

February 14, 2011 7:33 pm | by I-Micronews | Comments

Axsun Technologies, producer of MEMS-based lasers and optical engines for Optical Coherence Tomography (OCT) imaging systems, has launched an ultra speed 12-b resolution Data Acquisition board called the AXSUN DAQ for its swept laser OCT Engine products

TSMC scores strong sales performance in Jan. despite usually weak season

February 14, 2011 7:33 pm | by I-Micronews | Comments

Taiwan Semiconductor Manufacturing Co. (TSMC) saw its revenue for January rise 1.4% month on month, to a better-than-expected level of NT$35.3 billion (US$1.2 billion at US$1:NT$29), with its production running at over 95% capacity in the first quarter

Harvard University researchers fabricate MEMS paper sensors

February 14, 2011 7:32 pm | by I-Micronews | Comments

A team of researchers working at Harvard University have fabricated an MEMS force sensor from paper, making it cost- effective and almost disposable


Unilife fiscal 2011 2Q loss widens

February 14, 2011 1:45 pm | by The Associated Press | Comments

Medical safety product maker Unilife Corp. on Monday said its fiscal 2011 second-quarter loss widened on lower revenue from industrialization fees and higher costs.The company lost $10.4 million, or 19 cents per share, compared with a loss of $5.9 million, or 13 cents per share, during the same...

Varian Medical board approves buyback plan

February 14, 2011 1:45 pm | by The Associated Press | Comments

Varian Medical Systems Inc., which makes software and X-ray equipment for cancer clinics and cargo screenings, said Monday that its board of directors authorized the repurchase of an additional 12 million common shares through the end of its 2012 fiscal year.The company said the new...

S & P, Moody's raise Thermo Fisher ratings

February 14, 2011 1:45 pm | by The Associated Press | Comments

Standard & Poor's Ratings Service and Moody's Investors Service both raised their credit ratings on scientific instrument maker Thermo Fisher Scientific Inc. on Monday, as the company's operations continue to recover from recession lows.S&P lifted its corporate credit and senior unsecured ratings...

Kendle names Cutler new CEO in succession plan

February 14, 2011 12:45 pm | by The Associated Press | Comments

Clinical research company Kendle International Inc. said Monday it named Stephen Cutler president and CEO to replace Dr. Candace Kendle.Cutler, 51, is currently a senior vice president and chief operating officer. Kendle, 64 and a co-founder of Kendle, will continue to serve as chairman of the...

FDA Finalizes Regulation for Certain Software, Hardware Used With Medical Devices

February 14, 2011 10:30 am | by U.S. Food & Drug Administration | Comments

Today, the FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or...


Health Dialog names Bill Pelzar as new CIO

February 14, 2011 9:37 am | by Mass High Tech: The Journal of New England Technology | Comments

Boston's Health Dialog Services Corp. has hired Bill Pelzar, former Gartner Inc. executive, as the company's chief information officer.

FDA: Data gatherers won't need same OK as med devices

February 14, 2011 9:37 am | by Mass High Tech: The Journal of New England Technology | Comments

Saying that is providing a “less-burdensome path to market” for low-risk products used with medical devices, the U.S. Food and Drug Administration today set new rules for what it calls Medical Device Data Systems (MDDS) or Class I systems that perform tasks such as storing data collected...


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