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741 - 760 of 876 Benin Republic News Headlines Page 38 of 44 Pages
FDA Centennial
FDAnews - Sunday, August 13, 2006
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CMS Issues Guidance on Evidence-Based Coverage
FDAnews - Sunday, August 13, 2006
The Centers for Medicare & Medicaid (CMS) June 12 issued guidance on national coverage determinations ... more

States Efforts to Restrict Medical Product Marketing Could Effect Devices
FDAnews - Sunday, August 13, 2006
Medical product marketers are facing increasingly restrictive environments in a number of states, experts said at a recent conference on marketing ... more

FDA Hits Vapotherm With Warning Letter for GMP, QS Deficiencies
FDAnews - Sunday, August 13, 2006
The FDA sent devicemaker Vapotherm a June 12 warning letter for serious good manufacturing practices (GMP) and quality system regulation (QSR) ... 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FDA recently received comments on its “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials — Draft Guidance for Industry and FDA Staff,” issued May ...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

FDA Issues Warning Letter to Scooter Maker
FDAnews - Sunday, August 13, 2006
Broken bolts and screws on Rascal electric scooters caused seats to wobble and break off throughout 2005. In a few cases, users fell off and suffered cuts and bruises, the FDA said in a June 1 warning letter to the scooter manufacturer, Electric ... more

FDA Warns Dental Supply Firm About Lax Quality Controls
FDAnews - Sunday, August 13, 2006
The FDA issued a June 1 warning letter to Dux Industries of Oxnard, Calif., citing the company for failing to document quality controls and management review procedures, and for lacking a system to receive and review product ... more

Response to Guidance on Informed Consent for IVD Specimens
FDAnews - Sunday, August 13, 2006
Although the American Association for Clinical Chemistry (AACC) supports a recent FDA guidance on informed consent for in vitro diagnostic (IVD) device clinical trials, the group says several guidance details remain ... more

Brain Signals Can Be Turned Into Actions
FDAnews - Sunday, August 13, 2006
Researchers have found that brain signals from patients with severe, long-term paralysis can be translated through a computer to allow those patients to perform some physical ... more

Briefs
FDAnews - Sunday, August 13, 2006
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Device Recalls
FDAnews - Sunday, August 13, 2006
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FDA ISSUES NOTICE ON BIOPSY DEVICES
FDAnews - Sunday, August 13, 2006
The FDA recently issued a public health notice on the instructions for cleaning and sanitizing, or "reprocessing," ultrasound transducer assemblies used in biopsy ... more

DISETRONIC MEDICAL SYSTEMS RECALLS D-TRONPLUS INSULIN PUMP POWER PACKS DUE TO BATTERY DESIGN ISSUE
FDAnews - Sunday, August 13, 2006
Disetronic Medical Systems, based in Fishers, Ind., July 13 announced a voluntary nationwide recall of its D-TRONplus power packs for D-TRONplus insulin ... more

FDA PARTIALLY LIFTS CLINICAL HOLD ON CORAUTUS GENETICS TRIAL
FDAnews - Sunday, August 13, 2006
The FDA has partially lifted a clinical hold it imposed March 29 on a clinical trial conducted by Corautus ... more

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

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