Regulatory: Page 71

Do breast density laws affect radiologists' reporting?
By Kate Madden Yee
CHICAGO - Since 2009, almost half of U.S. states have adopted breast density notification laws, and there has been much discussion about how these laws have affected the use of supplemental imaging, such as ultrasound. But have they also affected how radiologists report breast density on mammography?
December 1, 2015
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FDA accepts Blue Earth's PET agent application
By AuntMinnie.com staff writers
Blue Earth Diagnostics announced that its new drug application filing for the PET agent fluciclovine has been accepted by the U.S. Food and Drug Administration (FDA) for priority review.
December 1, 2015
Densitas receives CE Mark, Canadian clearance
By AuntMinnie.com staff writers
Medical device firm Densitas has received the CE Mark from the European Commission and a medical device license from Health Canada for its DM-Density breast density assessment software.
November 30, 2015
Insightec's ExAblate Neuro gets Korean regulatory approval
By AuntMinnie.com staff writers
MR-guided focused ultrasound (MRgFUS) developer InSightec announced that its ExAblate Neuro system was approved by the Korean Ministry of Food and Drug Safety to treat movement, pain, and behavioral disorders.
November 29, 2015
FDA clears Siemens' Somatom CT for lung cancer screening
By AuntMinnie.com staff writers
Siemens Healthcare has received clearance from the U.S. Food and Drug Administration (FDA) for its Somatom CT systems for low-dose lung cancer screening.
November 29, 2015
Fuji readies new DR products for RSNA
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA plans to unveil two new digital radiography (DR) products at RSNA 2015 in Chicago.
November 26, 2015
EDDA nets FDA OK for IQQA software
By AuntMinnie.com staff writers
Advanced visualization software developer EDDA Technology has received clearance from the U.S. Food and Drug Administration (FDA) for its IQQA-Guide technology.
November 24, 2015
FDA says film printing optional for mammography
By Eric Barnes
In a guidance to mammography facilities, the U.S. Food and Drug Administration (FDA) said that printing breast images to hard-copy film is no longer necessary and can be performed at the discretion of individual centers.
November 22, 2015
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FDA clears Visaris Americas software
By AuntMinnie.com staff writers
Digital x-ray and PACS firm Visaris Americas has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Avanse software platform.
November 18, 2015
FDA warns of thyroid issues in infants after contrast
By AuntMinnie.com staff writers
The U.S. Food and Drug administration (FDA) has advised that a few cases of underactive thyroid have been reported in infants following the use of iodinated contrast media for x-ray and other medical imaging procedures.
November 16, 2015
Fuji SonoSite lands FDA nod for iViz scanner
By AuntMinnie.com staff writers
Ultrasound developer Fujifilm SonoSite has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its iViz portable ultrasound device.
November 16, 2015
AMIA urges CMS to rethink payment policies
By AuntMinnie.com staff writers
Officials from the American Medical Informatics Association (AMIA) are urging the U.S. Centers for Medicare and Medicaid Services (CMS) to use new payment policies to reassess how providers are required to use informatics tools, and to rethink how quality is measured in a digital world.
November 16, 2015
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