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Some Doctors Cutting Back on Imaging Device Purchases Due to Proposed Cuts
FDAnews - Sunday, August 13, 2006
Some doctors are buying fewer medical devices because of planned cuts to Medicare reimbursements for certain medical imaging services. The cuts are slated to start in January ... more

Greater Focus on PR Essential in Device and Diagnostics Industry
FDAnews - Sunday, August 13, 2006
Image may not be everything, but more device and diagnostics manufacturers are working to keep theirs as positive as ... more

FDA: Catheter Maker Had No Premarket Clearance for Devices
FDAnews - Sunday, August 13, 2006
Advanced Medical Systems’ Cholangio catheters were adulterated and misbranded because the company did not have the required premarket clearance from the FDA for the device, said a July 13 agency warning ... 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

Despite Short-Term Costs, Guidant Acquisition Seen as Boon to Abbott
FDAnews - Sunday, August 13, 2006
Analysts are projecting a sunny outlook for Abbott Laboratories based on 2006 second-quarter results — despite some company challenges.At first glance, the company may seem to be faring worse than it actually is, said stock market website www.SeekingAlpha.com Editor Jonathan ... more

FDA Calls Blood Warmer Adulterated
FDAnews - Sunday, August 13, 2006
Gaymar Industries, which makes blood warmers, received a June 8 FDA warning letter saying it failed to keep appropriate records of complaints that some of the devices were overheating or ... more

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

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

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