Regulatory: Page 73

Varian gets Saudi OK for proton therapy system
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received clearance from the Saudi Food and Drug Authority (FDA) to market its ProBeam proton therapy system.
January 10, 2016
Materialise hit by regulatory snag
By AuntMinnie.com staff writers
3D software developer Materialise has received a not substantially equivalent (NSE) letter from the U.S. Food and Drug Administration (FDA) in response to a 510(k) submission for its x-ray knee guide system.
December 21, 2015
Biotronik gets FDA nod for MRI-compatible ICD systems
By AuntMinnie.com staff writers
Biomedical device company Biotronik has received U.S. Food and Drug Administration (FDA) clearance to use its Iperia implantable cardioverter defibrillator (ICD) systems with MRI studies.
December 21, 2015
Medtronic brings MRI-compatible ICD to Canada
By AuntMinnie.com staff writers
Interventional device developer Medtronic Canada has received a Health Canada license for its Evera MRI SureScan implantable cardioverter defibrillator (ICD) system.
December 20, 2015
ACR applauds new federal spending bill
By AuntMinnie.com staff writers
The American College of Radiology (ACR) is applauding passage of the $1.15 trillion Consolidated Appropriations Act by Congress on December 18.
December 17, 2015
New U.S. budget brings good news for mammography
By Kate Madden Yee
It could be a Christmas miracle: Both houses of Congress have introduced legislation that includes good news for mammography screening.
December 16, 2015
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It's final: CMS rejects NaF-PET coverage
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has reaffirmed its decision not to reimburse for sodium fluoride (NaF) PET scans to detect bone metastases.
December 14, 2015
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
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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
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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
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