Archive for ◊ February, 2010 ◊

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• Friday, February 26th, 2010

A complaint filed in federal court last week “alleges Medtronic Inc. illegally marketed a relatively obscure medical device called a biliary stent in ways not approved by federal regulators,” The (Minneapolis-St. Paul) Star Tribune reports. “The complaint was filed in U.S. District Court in Boston by two former employees who claim they were harassed and then […]

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• Friday, February 26th, 2010

Federal authorities yesterday formally charged Boston Scientific Corp. with criminal violations in connection with faulty reports made by its Guidant heart-device unit to the Food and Drug Administration. The charges were filed in a US district court in St. Paul, nearly three months after Boston Scientific reached a $296 million agreement with the Department of Justice […]

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• Thursday, February 25th, 2010

About 72% of device makers worldwide believe the performance of their businesses will be better in 2010 compared with this year, according to a survey by consulting and research firm Emergo Group. The survey noted that such optimism can be attributed to sales increases experienced by about 37% of all firms during the past three […]

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• Thursday, February 25th, 2010

A spray-on skin product and an injectable cell therapy forheart attack patients are among 17 regenerative medicine technologies that will be showcased during the Translational Regenerative Medicine Forum, set for April 6-8 in Winston-Salem. Representatives from 17 startup biotech companies have been selected to present their technologies to a group of venture capitalists and companies […]

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• Thursday, February 25th, 2010

Wider adoption of the practice of recycling medical equipment including laparoscopic ports and durable cutting tools typically tossed out after a single use could save hospitals hundreds of millions of dollars annually and curb trash at medical centers, the second-largest waste producers in the United States after the food industry. The recommendation, made in an […]

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• Thursday, February 25th, 2010

InfraReDx, Inc., an innovative medical device company focused on developing novel diagnostic imaging technologies to accurately identify and characterize diseased intracoronary tissues, announced that the Company will be exhibiting at LUMEN 2010, the world’s premier ST-elevation myocardial infarction (STEMI) meeting, to be held February 25-27, 2010 at the Loews Miami Beach Hotel in Miami Beach, […]

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• Thursday, February 25th, 2010

NEW YORK–(BUSINESS WIRE)–Small Bone Innovations, Inc. (SBi), a leading, privately-held orthopedics company focused exclusively on technologies and treatments for the small bones & joints, announced that it has received 510(k) pre-market clearance notifications from the U.S. Food and Drug Administration (FDA) for Mini-Rail Fixation System (‘Mini-Rail System’) and large Cannulated Screw System for use in […]

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• Thursday, February 25th, 2010

PLEASANTON, Calif., Feb. 25 /PRNewswire/ — TriReme Medical, Inc. (TMI) announced today that it has received FDA clearance for its newest product, the Glider™ balloon catheter, for percutaneous transluminal angioplasty (PTA) of lesions in the peripheral vasculature including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Approximately 12 million Americans are affected by peripheral […]

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• Thursday, February 25th, 2010

MILPITAS, Calif., Feb. 24 /PRNewswire/ — LifeScan, Inc. is conducting a voluntary recall in the United Statesof eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home.  The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher […]

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• Thursday, February 25th, 2010

WASHINGTON, Feb. 24 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration and the National Institutes of Health today unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients. The initiative involves two interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into […]