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Benin Battles in Vain With Fuel Smugglers
Topix - Sunday, August 13, 2006
With his flowery red shirt sleeves pulled up, Fatiou Olade sucks at a small red tube to siphon gasoline into a jerrycan from a 50-liter plastic ... more

AKSYS WARNING LETTER ADDS TO COMPANY'S TROUBLES
FDAnews - Sunday, August 13, 2006
The FDA sent personal hemodialysis (PHD) system maker Aksys a June 8 warning letter saying that its devices were adulterated and misbranded because the company changed its recommendation for how long patients should use the system without requesting premarket ... more

FDA ISSUES TWO NEW GUIDANCES
FDAnews - Sunday, August 13, 2006
A guidance posted July 26 on the FDA website describes how in vitro diagnostic devices to measure fecal calprotectin in human stool specimens can comply with the special controls requirement for Class II ... more

STUDY POINTS TO RISK OF ADVERSE EVENTS FROM USE OF HEMOSTASIS DEVICES
FDAnews - Sunday, August 13, 2006
A study in the Journal of Invasive Cardiology published July 26 found an increased risk of serious adverse events following cardiac catheterization with certain devices used in hemostasis, a process to stop ... more

STRATAGENE SAYS JURY DETERMINED THAT INVITROGEN'S 4,981,797 PATENT IS VALID
FDAnews - Sunday, August 13, 2006
Stratagene Corp. said the jury determined that Invitrogen Corp.'s 4,981,797 patent is valid and that Stratagene infringed that patent by making and selling its competent E. coli cell ... more

TEST HELPS IDENTIFY PATIENTS AT LOW RISK FOR RECURRING BLOOD CLOTS
FDAnews - Sunday, August 13, 2006
A test that measures the generation of a certain protein involved with blood clotting can help determine whether patients who have experienced a venous blood clot are at low risk of developing another blood clot, and thus avoiding anticoagulant treatment and its possible side effects, according to a study in ... more

INFRASCAN ANNOUNCES FIRST PATIENTS ENROLL IN CLINICAL TRIAL IN BRAIN HEMATOMA DETECTION
FDAnews - Sunday, August 13, 2006
InfraScan, a medical device firm specializing in brain injury diagnostic products, announced that more than 15 patients have been enrolled in its clinical trial for hematoma ... more

ASDAQ DEAL PRECURSOR TO IPO FOR CAMBRIDGE MEDICAL DEVICES COMPANY?
FDAnews - Sunday, August 13, 2006
A Cambridge company developing technology that could save lives in intensive care units has signed a breakthrough commercialisation deal that could spell an imminent ... more

ARTIFICIAL SPINAL DISC GENERATES CONTROVERSY
FDAnews - Sunday, August 13, 2006
Darla Russell and Leah Coppersmith had chronic lower back problems when their doctors suggested an artificial spinal disc implant to reduce their pain and restore their ... more

NEW MRI TECHNIQUE QUICKLY BUILDS 3-D IMAGES OF KNEES
FDAnews - Sunday, August 13, 2006
A faster magnetic resonance imaging (MRI) data-acquisition technique will cut the time many patients spend in a cramped magnetic resonance scanner, yet deliver more precise 3-D images of their ... more


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Benin ex-minister nabbed for drugs
Topix - Sunday, August 13, 2006
Benin ex-minister nabbed for drugs Tuesday July 25, 2006 16:00 - COTONOU - Benin's former finance minister Cosme Sehlin was arrested overnight Monday on suspicions of drugs trafficking after police seized 100 ... ... more

A Free Market Case Study
allAfrica.com - Sunday, August 13, 2006
Benin is neither populous nor mineral rich, which means that it is not an obvious candidate for rapid development. Having won the nickname, the "Cuba of Africa" during its heady Communist-Leninist days of the 70s and 80s Benin underwent a remarkable and dramatic ... more

Insurance Continue Unbeaten Run
allAfrica.com - Sunday, August 13, 2006
Insurance Football Club of Benin on Saturday at the Samuel Ogbemudia stadium, Benin City outclassed hard fighting El-Kanemi Football Club of Maiduguiri 2-1 to consolidate on their three matches unbeaten run. The Edo Arsenal, started the match with more determination considering their position on the Globacom Premier League with Cletus ... more

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

Devicemakers Can Avoid Blame for Inflated Costs With New Competitive Strategies
FDAnews - Sunday, August 13, 2006
Device and diagnostics makers can avoid being blamed for inflated healthcare costs by focusing on competitive strategies that add value to their products, experts ... more

Firms on Different Wavelengths About Expanded Bandwidth for Wireless Devices
FDAnews - Sunday, August 13, 2006
The FCC is considering whether to expand available radio frequency (RF) for implanted and body-worn wireless devices, but manufacturers disagree on whether additional RF is ... more

FDA Issues Guidances on Conflict of Interest
FDAnews - Sunday, August 13, 2006
The FDA is taking a more active role in the growing debate over the independence of its advisory committee members in an effort to head off potential legislative ... more

New Information on IVD Test for Inflammatory Bowel Disease
FDAnews - Sunday, August 13, 2006
The FDA July 27 published guidance on Class II special controls for in vitro devices (IVDs) used to diagnose inflammatory bowel disease ... more

Manufacturer Implanted Devices Without Written Consent, FDA Says
FDAnews - Sunday, August 13, 2006
Galesburg Orthopedic Services did not obtain written consent from patients before implanting its devices, nor did it obtain FDA and institutional review board (IRB) approval before allowing patients to participate in clinical trials, the FDA said in a recent warning ... more

FDA: Substitute Saliva Is a Regulated Device, Not Cosmetic
FDAnews - Sunday, August 13, 2006
In a July 10 warning letter, the FDA told the maker of a dry mouth reliever that its product is considered a saliva substitute, and therefore should be regulated as a medical ... more

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