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FDA Scientists Report Political Influence Over Their Work
FDAnews - Sunday, August 13, 2006
Many FDA scientists are subject to “pervasive and dangerous political influence” that has affected medical device approvals, according to a new Union of Concerned Scientists (UCS) survey report issued July ... more

Briefs
FDAnews - Sunday, August 13, 2006
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State Legislation Update
FDAnews - Sunday, August 13, 2006
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CORRECTIONS
FDAnews - Sunday, August 13, 2006
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Device Recalls
FDAnews - Sunday, August 13, 2006
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RESPONSE TO GUIDANCE ON INFORMED CONSENT FOR IVD SPECIMENS
FDAnews - Sunday, August 13, 2006
Although the American Association for Clinical Chemistry (AACC) supports a recent FDA guidance on informed consent for in vitro diagnostic device clinical trials, the group says several guidance details remain ... more

NIH FISCAL 2007 SPENDING BILL FALLS SHORT OF R&D INFLATION, EMERGING TECHNOLOGY COSTS, GROUPS SAY
FDAnews - Sunday, August 13, 2006
Biomedical research groups are disappointed in a Senate-approved NIH funding bill they say fails to cover inflation and new technology ... more

FDA ANNOUNCES CLASSIFICATION OF INFUSION DEVICE RECALL AS CLASS I
FDAnews - Sunday, August 13, 2006
The FDA July 21 announced it has classified a recent recall of Disetronic's Accu-Chek Ultraflex-1 infusion set as Class ... more

COURT RULES IN FAVOR OF ROCHE DIAGNOSTICS IN PATENT DISPUTE WITH ENZO BIOCHEM
FDAnews - Sunday, August 13, 2006
Roche Diagnostics announced that a district judge in New York has ruled in favor of Roche Diagnostics on important aspects of patent infringement allegations brought by Enzo ... more

ATRICURE RECEIVES FDA 510(K) CLEARANCE FOR MULTIFUNCTIONAL ISOLATOR TRANSPOLAR PEN SYSTEM AND RELEASES NEW ISOLATOR TRANSPOLAR OPEN CLAMP
FDAnews - Sunday, August 13, 2006
AtriCure, Inc., a medical device company focused on developing, manufacturing and selling innovative surgical devices, announced that it has received Food and Drug Administration (FDA) 510(k) clearance for its Isolator Transpolar Pen System (Pen) for pacing, sensing, stimulating, and recording during the evaluationof cardiac arrhythmias in addition to its currently ... more


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ABBOTT REMINDS U.S. FREESTYLE AND FREESTYLE FLASH BLOOD GLUCOSE METER USERS TO VERIFY UNITS OF MEASURE WHEN THEY TEST
FDAnews - Sunday, August 13, 2006
Abbott is reminding users of its FreeStyle and FreeStyle Flash blood glucose meters in the United States to check to make sure their meter is displaying the correct unit of measure (milligrams per deciliter, mg/dL) and strip calibration code each time they ... more

HUTCHINSON TECHNOLOGY RECEIVES FDA CLEARANCE FOR INSPECTRA STO2 TISSUE OXYGENATION MONITOR
FDAnews - Sunday, August 13, 2006
Hutchinson Technology Incorporated announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to begin marketing its InSpectra StO2 Tissue Oxygenation ... more

THE EUROPEAN OPHTHALMIC DEVICE MARKET IS EXPECTED TO GROW AT A RATE OF 4% OVER THE NEXT 5 YEARS
FDAnews - Sunday, August 13, 2006
Research and Markets has announced the addition of the new Millennium Research report "European Markets for Ophthalmic Devices" to their ... more

HE 'MEDICAL ARMS RACE'
FDAnews - Sunday, August 13, 2006
The 64-slice CT scanner is a modern marvel ? creating vivid pictures of internal organs and blood vessels in less time than older diagnostic imaging ... more

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

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