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Device Trial Sponsors Must Be Careful in Wording Trial Agreements
FDAnews - Saturday, October 07, 2006
Device clinical trial sponsors must word their agreements with investigators and trial sites even more carefully in certain areas than sponsors of drug trials, according to a speaker at a recent FDA Clinical Trial Requirements Conference in ... more

FDA, Industry Respond to Final HRS Guidelines
FDAnews - Saturday, October 07, 2006
Regulators and devicemakers pledged to implement many of the Heart Rhythm Society (HRS) recommendations released Sept. 28 that ask the FDA, industry and physicians to do a better job of tracking heart device malfunctions and communicating device adverse event ... more

FDA Cites Medtronic for Missing Filing Deadline
FDAnews - Saturday, October 07, 2006
Medtronic Vascular violated federal regulations by failing to submit an interim postmarket surveillance report on time, the FDA said in a Sept. 27 warning ... more

FDA Issues Detailed Requirements For Device Reprocessors
FDAnews - Saturday, October 07, 2006
Device reprocessors must adhere to new data requirements in their cleaning and sterilization methods, the FDA said in recent ... more

'LATEX FREE' DEVICES CONTAINED LATEX, WARNING LETTER SAYS
FDAnews - Saturday, October 07, 2006
Medex labeled two of its devices "latex free" but had to recall the devices because they contained latex, the FDA said in a Sept. 5 warning ... more

OUTSOURCING COMES WITH BENEFITS, CHALLENGES FOR DEVICE FIRMS
FDAnews - Wednesday, October 04, 2006
Device firms that send manufacturing operations and clinical trials overseas may save time and money but will also need to exercise more vigilance over their suppliers, experts ... more

THREE FIRMS INVOLVED IN TALKS TO ACQUIRE VISION SYSTEMS
FDAnews - Wednesday, October 04, 2006
Medical technology firm Danaher and software systems manufacturer Ventana are engaged in discussions on a possible joint acquisition of medical technology firm Vision Systems, the Australian Stock Exchange said Oct. ... more

FDA APPROVES CARDIACASSIST'S TANDEMHEART ESCORT CONTROLLER
FDAnews - Wednesday, October 04, 2006
CardiacAssist has received FDA 510(k) market approval for its new TandemHeart Escort Controller, the firm said Oct. ... more

BECKMAN COULTER BUYING LUMIGEN
FDAnews - Wednesday, October 04, 2006
Beckman Coulter agreed to acquire Lumigen of Southfield, Mich., for $185 million in ... more

SPIRE TO DEVELOP NANOTECHNOLOGY COATING FOR WEAR-RESISTANT ORTHOPEDIC DEVICES
FDAnews - Wednesday, October 04, 2006
Spire Corporation announced that it has been awarded a $399,243, two-year grant from the National Institutes of Health-National Institute of Arthritis and Muskuloskeletal and Skin Diseases (NIH-NIAMS) to develop a new type of nanotechnology coating for wear-resistant orthopedic devices, with specific applications for spinal ... more


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DEVICE DTC ADS A WHOLE DIFFERENT BALL GAME THAN PHARMA ADS, EXPERTS SAY
FDAnews - Tuesday, October 03, 2006
While devicemakers looking to expand their direct-to-consumer (DTC) advertising efforts can benefit from drugmakers' experiences, the promotional needs of each are worlds apart, experts ... more

BD BOWING OUT OF BLOOD GLUCOSE MONITORING MARKET
FDAnews - Tuesday, October 03, 2006
Becton Dickinson (BD) will exit the blood glucose monitoring market, the firm said Sept. ... more

FDA IMMUNOLOGY DEVICES PANEL TO MEET
FDAnews - Tuesday, October 03, 2006
The Immunology Devices Panel of the FDA's Medical Devices Advisory Committee will hold a public meeting Nov. ... more

BOYNTON MAN SUES CORDIS OVER PROBLEMS WITH DRUG IN STENT
FDAnews - Tuesday, October 03, 2006
Implanting a Cordis Corp. stent in Herbert Entenberg's body might have saved his life, but it also made his life a living hell, says a Boynton Beach retiree who has filed a lawsuit against the ... more

GROUPS BACK REGULATION OF GENETIC TESTS
FDAnews - Tuesday, October 03, 2006
Stronger regulations should be implemented for genetic testing, a consortium of groups argued ... more

NOVEL TECHNIQUE WOULD PREVENT RE-CLOGGED ARTERIES
FDAnews - Tuesday, October 03, 2006
Researchers at the Technion-Israel Institute of Technology are proposing a revolutionary approach to prevent the common post-balloon angioplasty problem of restenosis (re-clogging of coronary ... more

XENOMICS ANNOUNCES DEVELOPMENT OF TEST FOR THE GENETIC MARKER FOR ACUTE MYELOID LEUKEMIA (AML)
FDAnews - Tuesday, October 03, 2006
Xenomics, Inc., the source of next-generation medical DNA diagnostic tests, announced that it has developed a proprietary test for the detection of NPM gene mutations, a recently discovered genetic marker for Acute Myeloid Leukemia ... more

ESSEL PROPACK WILL START PACKING POWER
FDAnews - Tuesday, October 03, 2006
Diversification and de-risking the business model seems to be the theme at Essel Propack Ltd ... more

NZ BIOTECH FIRM TAKES CANCER TEST TO EUROPE
FDAnews - Tuesday, October 03, 2006
A new licensing deal with a German diagnostic firm could see a cancer test developed by Dunedin-based Pacific Edge Biotechnology hit a market worth millions in a ... more

FDA, INDUSTRY RESPOND TO HRS FINAL GUIDELINES
FDAnews - Monday, October 02, 2006
The FDA, AdvaMed and devicemakers Boston Scientific and St. Jude Medical issued statements Sept. 28 in support of the Heart Rhythm Society's final recommendations on heart device ... more

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