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Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff. Read More...
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Dublin, Ireland, August 11th, 2008 – ICON plc (NASDAQ: ICLR; ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that its Medical Imaging division...
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MARLBOROUGH, Mass.--(BUSINESS WIRE)--EXACT Sciences Corporation (NASDAQ: EXAS - News) today announced the published results of a study in which stool and blood plasma were assessed, in a head-to-head comparison, for the detection of colorectal cancer...
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BLOOMINGTON, Ind.--(BUSINESS WIRE)--Further innovating the field of advanced aortic disease repair technologies, Cook Medical today announced approval from the U.S. Food and Drug Administration (FDA) to market its improved Zenith Abdominal Aortic Aneurysm...
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The Food and Drug Administration (FDA) is publishing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2009. Read More...
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SHENZHEN, China, July 31 /Xinhua-PRNewswire/ -- Winner Medical Group Inc. , a leading manufacturer and the largest exporter by volume in the medical dressing industry (medical and wound care products) in China, today announced that it will release unaudited...
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MURRIETA, CA--(MARKET WIRE)--Jul 31, 2008 -- CLX Medical, Inc. (OTC BB:CLXN.OB - News), which is focused on the launch and distribution of unique medical diagnostic testing products, today announced that the company has completed the major elements of...
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SHENZHEN, China, July 17 /Xinhua-PRNewswire/ -- Winner Medical Group Inc. , a leading manufacturer and the largest exporter by volume in the Chinese medical dressing industry (medical and wound care products), today announced that it has been notified...
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TORONTO, July 10 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc. today announced that it has entered into a exclusive distribution agreement in Russia with BB Medical for Spectral's Endotoxin Activity Assay (EAA(TM)), the only FDA cleared assay...
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LANGHORNE, Pa., July 8, 2008 (PRIME NEWSWIRE) -- Power Medical Interventions(r), Inc. (NasdaqGM:PMII - News), a leader in developing and commercializing Intelligent Surgical Instruments(tm), announced today that it has submitted a special premarket notification...
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MINNEAPOLIS, July 7 /PRNewswire-FirstCall/ -- ATS Medical, Inc. , manufacturer and marketer of state-of-the-art cardiac surgery products and services, today reported preliminary revenue results for the second quarter ended June 28, 2008. Read More...
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LONDON--(BUSINESS WIRE)--Premier Research Group Limited, the international pharmaceutical services company, announces that its subsidiary, Premier Research Group SA, has earned ISO 13485:2003 certification in support of its global medical device operations...
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AUSTIN, Texas--(BUSINESS WIRE)--Rules-Based Medicine, Inc. (RBM), the leading multiplexed biomarker testing laboratory for the life sciences industry, announced today that it has commercialized a new biomarker panel to aid pharmaceutical and biotech companies...
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PITTSBURGH, June 30, 2008 – Cohera Medical Inc. today named Richard L. Wonsettler to the newly created position of vice president of finance and CFO. Read More...
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VANCOUVER, June 26 /PRNewswire-FirstCall/ - Response Biomedical Corporation (TSX: RBM, OTCBB: RPBIF) announced today that it has entered into an agreement granting rights to Roche Diagnostics to market its line of cardiovascular point-of-care (POC) tests...
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