Regulatory: Page 72

FDA clears Medtronic brain stimulation for MR use
By AuntMinnie.com staff writers
Interventional device developer Medtronic announced that the U.S. Food and Drug Administration (FDA) has cleared parts of its Activa portfolio of deep brain stimulation neurostimulators for full-body MRI scans.
December 8, 2015
FDA reminds PACS users about compliance requirements
By Erik L. Ridley
Is your institution staying on top of its PACS maintenance responsibilities? If not, you'd better be: The U.S. Food and Drug Administration (FDA) is warning healthcare facilities that it may take compliance action if their PACS fails and images are lost due to preventable reasons.
December 8, 2015
2013 09 06 11 46 32 375 Fda Logo 200
FDA clears VidiStar's nuclear software
By AuntMinnie.com staff writers
PACS developer VidiStar has announced U.S. Food and Drug Administration (FDA) 501(k) clearance of its HeartView nuclear software.
December 6, 2015
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
2015 11 18 11 33 21 656 Rsna2015 Bug 200
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
2013 09 06 11 46 32 375 Fda Logo 200
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
Previous Page
Page 72 of 304
Next Page