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DENIAL OF REQUEST FOR CHANGE IN CLASSIFICATION OF BREATHING FREQUENCY MONITOR AND ELECTROENCEPHALOGRAPH
FDAnews - Sunday, August 13, 2006
The Food and Drug Administration (FDA) is denying the petitions submitted by IM Systems to reclassify the SleepCheck, the ActiTrac, and PAM-RL devices from class II (special controls) to class I (general ... more

BANDAGE GETS FDA APPROVAL
FDAnews - Sunday, August 13, 2006
Tissue Technologies LLC, which makes bandages for non-healing wounds, had its first product approved by the U.S. Food and Drug Administration this ... more

J&J BUYS ENSURE MEDICAL
FDAnews - Sunday, August 13, 2006
Cordis, the heart and vascular device unit of Johnson & Johnson, said Thursday it acquired privately held wound-closure startup Ensure ... more

DURAMED SIGNS SUPPLY/MARKETING DEAL FOR MEDICAL DEVICE
FDAnews - Sunday, August 13, 2006
Duramed Pharmaceuticals has partnered with an Israeli company to bring to market a device that would help detect pregnancy ... more

BIOLASE ANNOUNCES FDA CLEARANCE OF ITS OCULASE MD LASER SYSTEM FOR OPHTHALMOLOGY
FDAnews - Sunday, August 13, 2006
BIOLASE Technology, Inc., a medical technology company that develops, manufactures and markets lasers and related products focused on technologies for improved applications and procedures in dentistry and medicine, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) allowing it to market its OCULASE ... more

ENCORE BUYOUT SPAWNS SHAREHOLDER LAWSUIT
FDAnews - Sunday, August 13, 2006
An Encore Medical Corp. shareholder is suing over its proposed $870 million sale to a private New York investment ... more

Beninese demand changes, as Boni marks 100 days in office
Topix - Sunday, August 13, 2006
More than 100 days after t he inauguration of Yayi Thomas Boni as Benin President, his compatriots are already asking for the political and economic changes which the former banker promised on his ... more

EXPERTS ASK FDA TO CLARIFY, SIMPLIFY BAYESIAN STATISTICS GUIDANCE
FDAnews - Sunday, August 13, 2006
The FDA recently received comments on its "Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials ? Draft Guidance for Industry and FDA Staff," issued May ... more

MEDTRONIC ENTERS INTO $40 MILLION SETTLEMENT WITH DOJ OVER WHISTLEBLOWER ALLEGATIONS
FDAnews - Sunday, August 13, 2006
The Department of Justice (DOJ) and Medtronic announced July 18 the firm will pay the government $40 million to settle civil allegations the firm's Sofamor Danek division paid kickbacks to healthcare professionals (HCPs) inducing them to use Medtronic's spinal ... more

FDA APPROVES ABBOTT'S AUTOMATED DIAGNOSTIC FOR HEPATITIS B SURFACE ANTIGEN
FDAnews - Sunday, August 13, 2006
The FDA July 18 said it had approved the first fully automated product that both screens and confirms tests for hepatitis B surface antigen ... more


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FDA ISSUES OPHTHALMIC PANEL MEETING SUMMARY; SPECIFIES SAFETY CONCERNS REGARDING VISIONCARE EYE DEVICE
FDAnews - Sunday, August 13, 2006
The FDA July 18 provided an explanation of the safety concerns of its Ophthalmic Devices Panel in recommending against approval for VisionCare's Implantable Miniature Telescope ... more

FDA APPROVES FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE
FDAnews - Sunday, August 13, 2006
The FDA announced it has approved the Fuji Computed Radiography Mammography (FCRm) manufactured by FujiFilm Medical System ... more

ABBOTT, MEDINOL SETTLING PATENT SUIT AGAINST ABBOTT STENT
FDAnews - Sunday, August 13, 2006
Abbott Laboratories Inc. is finalizing a patent infringement case settlement with Israeli company Medinol Ltd. that could free Abbott's Xience drug-coated stent medical device from an entanglement as Abbott works to bring the product to the U.S. ... more

SMITH & NEPHEW RECEIVES FDA APPROVAL FOR EXOGEN 4000+* BONE HEALING SYSTEM
FDAnews - Sunday, August 13, 2006
Smith & Nephew's Orthopaedic Trauma & Clinical Therapies division announced FDA approval for its EXOGEN 4000+* Bone Healing ... more

NEW RESEARCH VALIDATES INNOVATIVE DIAGNOSTIC TESTING APPROACH TO SLEEP APNEA PATIENT CARE WITHIN THE VETERANS AFFAIRS HEALTH SYSTEM
FDAnews - Sunday, August 13, 2006
The Department of Veterans Affairs (VA) has solved a serious ... more

S3 INVESTMENT COMPANY SUBSIDIARY SINO UJE RECEIVES DISTRIBUTION RIGHTS TO MEDICAL DIAGNOSTIC TESTING PRODUCTS IN CHINA MARKET
FDAnews - Sunday, August 13, 2006
S3 Investment Company, Inc., announced that subsidiary SINO UJE, Ltd. has been awarded distribution rights in China to the HandiLab line of medical diagnostic tests from Zonda Incorporated, a California-based ... more

World Bank's Wolfowitz hails Benin as Africa model
Topix - Sunday, August 13, 2006
World Bank President Paul Wolfowitz praised Benin on Wednesday as a democratic example that other countries in West Africa could learn ... more

France: The Beginnings of Affirmative Action
Global Voices Online - Sunday, August 13, 2006
Says (Fr) France-based Senegalese blogger Seckasysteme about the allegedly affirmative-action induced hiring and debut of Black French newsanchor Harry Roselmack on French national television: “Roselmack’s (…) professional competence and the recognition he has earned from his peers is so obvious that even the ... more

Full Issue in PDF Format
FDAnews - Sunday, August 13, 2006
View the entire issue in PDF ... more

Medtronic Enters $40 Million Settlement Over Whistleblower Allegations
FDAnews - Sunday, August 13, 2006
The Department of Justice (DOJ) and Medtronic announced July 18 the firm will pay the government $40 million to settle a civil suit alleging that the firm’s Sofamor Danek division paid kickbacks to healthcare professionals to induce them to use Medtronic’s spinal ... more

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