Regulatory: Page 199

FDA issues draft guidance on CAD
By Erik L. Ridley
In what may be both good and bad news for the computer-aided detection (CAD) software industry, the U.S. Food and Drug Administration has released its long-awaited draft guidance for CAD technology.
October 21, 2009
Is breast screening oversold? And, GE to buy ONI; FDA issues CAD rules
By Brian Casey
October 21, 2009
ScImage gets Canada nod
By AuntMinnie.com staff writers
PACS vendor ScImage has received a medical device license from Health Canada to distribute its PicomEnterprise radiology and cardiology PACS offering.
October 20, 2009
Philips receives FDA warning letter
By AuntMinnie.com staff writers
Philips Healthcare received a warning letter earlier this month from the U.S. Food and Drug Administration for violating several procedural regulations at its Andover, MA, facility.
October 20, 2009
FDA CT overdose probe focuses on Cedars-Sinai
By Brian Casey
Cedars-Sinai Medical Center in Los Angeles is the focus of a U.S. Food and Drug Administration investigation into more than 200 cases of overexposure to radiation during CT brain perfusion studies.
October 12, 2009
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FDA hangs fire on FFDM rules; VC for flat polyps
By Brian Casey
October 12, 2009
Mammography market awaits new FDA rules on FFDM regulation
By Kate Madden Yee
In 2006, the U.S. Food and Drug Administration said it wanted to make it easier for full-field digital mammography (FFDM) systems to get to market by relaxing the approval process. Three years later, the mammography industry is still waiting, a delay that some experts believe is contributing to higher prices for FFDM technology and limited access to new innovations.
October 12, 2009
Threats to ultrahigh-field MRI in Europe
By Denis Le Bihan
A new European directive designed to prevent workers from being exposed to high magnetic fields could potentially have a severe impact on MRI research, warns Denis Le Bihan, director of the NeuroSpin intense-field neuroimaging project at the CEA-Saclay Center in Gif-sur-Yvette, France.
October 8, 2009
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FDA issues radiation alert after CT brain perfusion overexposure
By Brian Casey
The U.S. Food and Drug Administration is investigating cases of radiation overexposure during CT brain perfusion scans conducted to aid the diagnosis and treatment of stroke. The agency said that at one particular facility, patients received radiation doses that were eight times the expected level.
October 7, 2009
2009 03 02 17 08 56 389 2009 03 02 Radioactive Symbol
SonoSite gets NanoMaxx FDA nod
By AuntMinnie.com staff writers
Compact-ultrasound technology developer SonoSite has received U.S. Food and Drug Administration 510(k) clearance for its NanoMaxx point-of-care ultrasound system.
October 5, 2009
Given gets pediatric PillCam nod
By AuntMinnie.com staff writers
Video-capsule endoscopy developer Given Imaging has received U.S. Food and Drug Administration clearance to market its products for pediatric applications.
October 1, 2009
Michelson gets nod for OCT scanner
By AuntMinnie.com staff writers
Michelson Diagnostics has won the CE Mark for clinical use of its VivoSight optical coherence tomography (OCT) scanner in Europe, in addition to nonclinical use worldwide.
September 17, 2009
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