Regulatory: Page 98

ACR to MEDCAC: Full coverage for low-dose CT needed
By AuntMinnie.com staff writers
The American College of Radiology (ACR) is urging the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to recommend national Medicare coverage of low-dose CT screening for patients at high risk for lung cancer.
April 23, 2014
CMS publishes agenda for April 30 CT lung screening meeting
By Eric Barnes
The U.S. Centers for Medicare and Medicaid Services (CMS) has released detailed information in preparation for the April 30 meeting of the Medicare Evidence Development and Coverage Advisory Committee to review the evidence on CT lung cancer screening.
April 23, 2014
FDA OKs Siemens' Somatom Force CT scanner
By AuntMinnie.com staff writers
Siemens Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its dual-source Somatom Force CT system.
April 22, 2014
Shimadzu lands FDA nod for digital R/F system
By AuntMinnie.com staff writers
Shimadzu Medical Systems USA has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sonialvision G4 universal digital radiography/fluoroscopy (R/F) system.
April 22, 2014
Ariz. governor signs breast density bill into law
By AuntMinnie.com staff writers
Arizona Gov. Jan Brewer signed a breast density bill into law on April 17, making the state the 15th in the U.S. to enact breast density legislation.
April 17, 2014
Philips temporarily halts production at Cleveland plant
By AuntMinnie.com staff writers
Philips Healthcare has temporarily halted production at its Cleveland manufacturing facility following an inspection by the U.S. Food and Drug Administration.
April 16, 2014
Calgary Scientific gets ResolutionMD OK in China
By AuntMinnie.com staff writers
Calgary Scientific has received certification for its ResolutionMD software from the China Food and Drug Administration for diagnosis on both Web and mobile devices for all imaging modalities.
April 16, 2014
FDA to host workshop on proposed IT framework
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration will hold a public workshop to discuss its proposed new framework for regulating health IT software.
April 14, 2014
NEC receives FDA clearance for new PACS display
By AuntMinnie.com staff writers
NEC Display Solutions of America has received U.S. Food and Drug Administration 510(k) market clearance for its MultiSync MD302C4 LCD.
April 14, 2014
GE lands FDA clearance for Revolution
By AuntMinnie.com staff writers
GE Healthcare has received U.S. Food and Drug Administration 510(k) clearance for its Revolution CT platform.
April 13, 2014
Federal regulatory plan for health IT wins positive reviews
By Erik L. Ridley
The new federal regulatory framework proposed earlier this month for healthcare IT software is getting generally positive reviews from the radiology community. A first look at the proposal indicates that it strikes a balance between promoting innovation and protecting patient safety.
April 13, 2014
2014 01 23 14 51 33 773 Data Stream 200
ClearMRI gets FDA nod for MRI coil
By AuntMinnie.com staff writers
ClearMRI Solutions has received U.S. Food and Drug Administration clearance for its new Helios-RG8 digital broadband MRI coil accessory kit.
April 10, 2014
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