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Firms Should Perform Early Safety Testing on Nanotech Products
FDAnews - Saturday, October 14, 2006
Firms should make safety research on nanoparticles a priority in their product design processes, because the FDA’s limited resources do not allow the agency to fully research the potential safety risks of nanotechnology, experts say (see related ... more

FDA Wants Injunction Against Devicemaker for Illegal Distribution
FDAnews - Saturday, October 14, 2006
The FDA announced Oct. 6 it is seeking a permanent injunction against Endotec for its illegal distribution of total joint replacement devices. Endotec has continued to distribute the devices despite warnings that it was breaking federal law, the agency ... more

Tips for Firms Responding To FDA Inspections
FDAnews - Saturday, October 14, 2006
A firm that disagrees with the results of an FDA inspection should bear in mind that the agency has ultimate discretion on taking enforcement action against a company, compliance consultant Nancy Singer told D&DL (see related ... more

Briefs
FDAnews - Saturday, October 14, 2006
... more

FDA ISSUES DETAILED REQUIREMENTS FOR DEVICE REPROCESSORS
FDAnews - Saturday, October 14, 2006
Device reprocessors must adhere to new data requirements in their cleaning and sterilization methods, the FDA said in recent ... more

GUIDANT WINS AGAIN IN MEDTRONIC PATENT LAWSUIT
FDAnews - Saturday, October 14, 2006
Boston Scientific announced Oct. 12 that the U.S. Court of Appeals for the Federal Circuit sided with Guidant (now part of Boston Scientific) in a patent case against ... more

BOVIE MEDICAL ANNOUNCES FDA CLEARANCE TO MARKET NEW LAPAROSCOPIC INSTRUMENTS
FDAnews - Saturday, October 14, 2006
Bovie Medical, a manufacturer and marketer of electrosurgical products, announced Oct. 12 it received FDA 510(k) clearance to market a new line of patent-pending advanced modular laparoscopic electrosurgical electrodes and a handle, aimed at the laparoscopic and arthroscopic ... more

DIAGNOSTIC ULTRASOUND CHANGES NAME TO VERATHON
FDAnews - Saturday, October 14, 2006
Diagnostic Ultrasound said it's changing its name to Verathon because it now sells products that aren't ultrasound ... more

RESEARCHERS DEVELOPING OFFICE-BASED CANCER SCREENING TEST
FDAnews - Saturday, October 14, 2006
Patients go to see their doctors for answers, but when it comes to cancer, physicians admit they need better tests to detect the earliest ... more

HOSPITAL PHONE BAN 'UNNECESSARY'
FDAnews - Saturday, October 14, 2006
Hospital restrictions on mobile phones are based largely on mythical safety risks and should be lifted, experts write in the British Medical ... more


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REPORT: BOSTON SCIENTIFIC TAKING SALES HIT FROM STENT WORRIES
FDAnews - Saturday, October 14, 2006
A new report says Boston Scientific is losing sales due to doctor concerns over the risks posed by drug-coated heart ... more

EPOCAL RECEIVES FDA APPROVAL TO MARKET THE EPOCTM BLOOD ANALYSIS SYSTEM
FDAnews - Saturday, October 14, 2006
Epocal is pleased to announce receipt of 510(k) clearance from the US Food and Drug Administration to market its first product ? the EPOCTM Enterprise Point of Care Blood Analysis System ? in the United ... more

BOSTON SCIENTIFIC TO SELL BOVIE DEVICE
FDAnews - Saturday, October 14, 2006
Bovie Medical, a maker of electrosurgical products, said Wednesday it entered an agreement to make a device that will be distributed and sold by Boston Scientific ... more

FEC Ratifies Maritime Boundary With Benin, Approves 1,335 Megawatts Gas Turbine Plant, Others
allAfrica.com - Friday, October 13, 2006
Federal Executive Council on October 4 ratified the treaty between Nigeria and Benin Republic signed in August 2005, which extends Nigeria's maritime boundaries beyond 200 nautical ... more

Vigilance helps avoid common swindles
Topix - Wednesday, October 11, 2006
Pleasanton resident Debbie Ayers got scammed on Craigslist while looking for a roommate. Comment ... more

FEC Ratifies New Maritime Boundary With Benin Republic, Approves 2 Gas Turbine Plants, Others
allAfrica.com - Tuesday, October 10, 2006
The Federal Executive Council (FEC) has ratified a treaty between Nigeria and Benin Republic, which extends Nigeria's maritime boundaries beyond 200 nautical ... more

DEVICEMAKERS NEED TO ENSURE THEIR PRODUCTS AREN'T 'REUSED AGAINST THEM'
FDAnews - Tuesday, October 10, 2006
If device reprocessors had more legal responsibility for adverse events linked to reused single-use devices (SUDs), the original devicemakers would not have to worry so much about liability when problems arise with the reused devices, an expert ... more

FDA SEEKS INJUNCTION AGAINST ORTHOPEDIC DEVICEMAKER
FDAnews - Tuesday, October 10, 2006
The FDA is seeking a permanent injunction against Endotec and three of its executives to stop their illegal distribution of unapproved total-joint replacement devices, the agency announced Oct. ... more

Full Issue in PDF Format
FDAnews - Saturday, October 07, 2006
View the entire issue in PDF ... more

Devicemakers Need to Ensure Their Products Aren’t ‘Reused Against Them’
FDAnews - Saturday, October 07, 2006
If device reprocessors had more legal responsibility for adverse events linked to reused single-use devices (SUDs), the originaldevicemakers would not have to worry so much about liability when problems arise with the reused devices, an expert ... more

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