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FDA OKS UPDATED KENSEY NASH SYSTEM
FDAnews - Sunday, August 13, 2006
Kensey Nash Corp. received Food and Drug Administration approval for the company's next generation TriActiv FX embolic protection ... more

JOHNSON & JOHNSON UNIT ORTHONEUTROGENA ACQUIRES ISRAEL BASED COLBAR LIFESCIENCE FOR UNDISCLOSED SUM
FDAnews - Sunday, August 13, 2006
Johnson & Johnson, a health care company, announced that on July 6, OrthoNeutrogena, a division of Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson company, has purchased privately held biotechnology company Colbar LifeScience Ltd., specializing in reconstructive medicine and tissue ... more

ELEKTA RECEIVES U.S. REGULATORY APPROVAL FOR TREATMENT PLANNING ON LEKSELL GAMMA KNIFE PERFEXION
FDAnews - Sunday, August 13, 2006
The U.S. Federal Drug Administration (FDA) announced a 510(k) pre-market clearance for Leksell GammaPlan PFX, the treatment planning system developed for Leksell Gamma Knife ... more

BESPAK PROFITS SOAR
FDAnews - Sunday, August 13, 2006
Medical devices group Bespak posted a hike in profits as it benefited from the approval of its diabetes inhaler drug and an increase in sales following the acquisition of King ... more

POLYMER-BASED 'MUSCLE-ACTUATOR' TECHNOLOGY LAUDED
FDAnews - Sunday, August 13, 2006
Frost & Sullivan has awarded its 2006 Actuator Technology Product Innovation of the Year Award to Artificial Muscle (AMI), for the development of the Universal Muscle Actuator ... more

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

FDA Centennial
FDAnews - Sunday, August 13, 2006
... more

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


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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
... more

Device Recalls
FDAnews - Sunday, August 13, 2006
... more

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

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