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FDA APPROVES URASSIST PORTABLE URINE COLLECTION SYSTEM
FDAnews - Tuesday, October 31, 2006
Preferred Medical Devices, Inc has just received FDA approval to market the UrAssist urine collection system, designed for limited-mobility ... more

TRINITY BIOTECH SALES IN EUROPE UP 30%
FDAnews - Tuesday, October 31, 2006
Diagnostic products maker Trinity Biotech said revenues for the three months to the end of September increased 25% to ... more

Young writers visiting Benin
Topix - Monday, October 30, 2006
Benin is one of the poorest countries in the world, but it also has been hailed as the poster child for democracy. Comment ... more

African airlines face landing restrictions despite pact
Topix - Monday, October 30, 2006
African countries have performed poorly in complying with the Yamoussoukro Declaration on open sky policy, which permits free movement of national airlines, airline officials said here Friday. Comment ... more

Full Issue in PDF Format
FDAnews - Saturday, October 28, 2006
View the entire issue in PDF ... more

EUROPEANS PROMOTE NANOTECHNOLOGY WITHOUT BORDERS
FDAnews - Saturday, October 28, 2006
Nanotechnology should be approached in a spirit of international collaboration and, as a part of this global picture, industry must be part of the solution in regulating nanotechnology, said Philippe Martin, directorate-general of the European Commission's (EC) Health and Consumer Protection branch and a principal administrator for the EC's nanotechnology ... more

CARDIOVASCULAR TECHNOLOGY CONFERENCE WRAPS UP; STUDIES ON STENT CLOTTING RISK REMAIN INCONCLUSIVE, ANALYSTS SAY
FDAnews - Saturday, October 28, 2006
While devicemakers at last week's Transcatheter Cardiovascular Therapeutics (TCT) conference presented clinical trial results in an effort to downplay the risk of clotting from the use of drug-eluting stents, analysts said the results of the trials are ... more

FDA: DENTAL PRODUCTS PANEL TO MEET ON SHORT NOTICE
FDAnews - Saturday, October 28, 2006
The FDA published a notice in the Oct. 26 Federal Register to announced the Dental Products Panel of its Medical Devices Advisory Committee will meet Nov. ... more

DOCTORS SAY SLOW ACTION ON STENTS LEADS TO HEART DEATHS
FDAnews - Saturday, October 28, 2006
Although a few thousand Americans might be dying needlessly from overuse of heart stents, prominent cardiologists said Thursday that far more are being killed each year by the failure of doctors to promptly clear coronary arteries and install stents when patients arrive at a hospital during a heart ... more

SYNERGETICS ASKS COURT TO DISMISS IRIDEX PATENT INFRINGEMENT CASE
FDAnews - Saturday, October 28, 2006
Synergetics USA Inc. made its first effort at having the courts throw out a pending patent infringement lawsuit brought by Iridex Corp. against the ... more


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KENSEY NASH RECEIVES CE MARK APPROVAL FOR NEW THROMCAT THROMBECTOMY CATHETER SYSTEM
FDAnews - Saturday, October 28, 2006
Kensey Nash Corporation announced that it has received CE Mark Approval for its ThromCat Thrombectomy Catheter System, which allows the sale of the product throughout the European ... more

DIGITAL ANGEL'S DEVICE FACES YEARS OF TESTING
FDAnews - Saturday, October 28, 2006
A new use for a microchip implant used to identify dogs and cats could be big news for patients with ... more

CONMED ENTERS INTO A DISTRIBUTION AGREEMENT WITH W.L. GORE & ASSOCIATES
FDAnews - Saturday, October 28, 2006
CONMED Corporation announced it entered into an agreement with W.L. Gore & Associates, a leading manufacturer of thousands of advanced technology products for the electronics, industrial, fabrics and medical ... more

PHARMAC UNDER FIRE AGAIN OVER ASTHMA INHALER
FDAnews - Saturday, October 28, 2006
Controversial medicine inhaler Salamol has been linked with deteriorating control of asthma in a study that has unleashed fresh criticism of ... more

DENTAL DEVICE COMPANY LACKS SUFFICIENT QUALITY STANDARDS
FDAnews - Friday, October 27, 2006
Thermoplastic Comfort Systems' dental repair devices are adulterated due to violations of current good manufacturing practice requirements, a recent FDA warning letter ... more

Firms Should Build Reimbursement Strategies Into Product Development
FDAnews - Wednesday, October 25, 2006
Every devicemaker should include a reimbursement strategy in the early stages of device development to ensure the viability of its products, experts said at the annual Regulatory Affairs Professionals Society conference Oct. ... more

Officials Moving to Update Imaging Display Standards to Accommodate New Technology
FDAnews - Wednesday, October 25, 2006
Updated performance standards are needed for device imaging displays due to rapid advances in imaging technology, experts said at an Oct. 12 ... more

OFFICIALS MOVING TO UPDATE IMAGING DISPLAY STANDARDS TO ACCOMMODATE NEW TECHNOLOGY
FDAnews - Wednesday, October 25, 2006
Updated performance standards are needed for device imaging displays due to rapid advances in imaging technology, experts said at an Oct. 12 ... more

FDA ISSUES DRAFT GUIDANCE ON PORTABLE INVASIVE BLOOD GLUCOSE MONITORING SYSTEMS
FDAnews - Wednesday, October 25, 2006
The FDA issued draft guidance Oct. 24 on portable invasive blood glucose monitoring systems ... more

ADVOCATES HIRE FIRM TO LOBBY FOR INCREASED FDA FUNDING
FDAnews - Wednesday, October 25, 2006
The FDA Alliance, a coalition of former agency officials, activists, industry associations and companies, has hired the law firm Patton Boggs to help the group advocate for increased FDA ... more

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