| 721 - 740 of 1000 Benin Republic News Headlines |
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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
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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
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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
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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
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'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
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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
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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.
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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.
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BECKMAN COULTER BUYING LUMIGEN
FDAnews
- Wednesday, October 04, 2006
Beckman Coulter agreed to acquire Lumigen of Southfield, Mich., for $185 million in
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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
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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
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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.
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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.
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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
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GROUPS BACK REGULATION OF GENETIC TESTS
FDAnews
- Tuesday, October 03, 2006
Stronger regulations should be implemented for genetic testing, a consortium of groups argued
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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
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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
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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
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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
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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
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