Regulatory: Page 99

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
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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
Koning gets Canadian approval for CT breast scanner
By AuntMinnie.com staff writers
Koning has received Canadian regulatory approval for its breast CT scanner, the firm's first clearance in North America.
April 10, 2014
FDA approves new indication for Guerbet contrast
By AuntMinnie.com staff writers
Guerbet has received approval from the U.S. Food and Drug Administration (FDA) for a new indication for its Lipiodol contrast agent.
April 9, 2014
FDA clears Analogic's handheld ultrasound
By AuntMinnie.com staff writers
Analogic has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its handheld Sonic Window ultrasound scanner.
April 9, 2014
Radiology ranks No. 7 of Medicare highest-paid specialties
By Kate Madden Yee
Well, it could have been worse. Radiology ranked seventh of the top 10 medical specialties that received the most in Medicare payments in 2012, based on data released April 9 by the U.S. Department of Health and Human Services.
April 9, 2014
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Is there a silver lining to the 2014 SGR patch?
By Kate Madden Yee
The latest effort to avert cuts to Medicare physician payments mandated by the sustainable growth rate (SGR) formula may be another in a long line of temporary fixes, but it also represents a victory for radiology, with language mandating the use of appropriateness criteria, transparency around payment policy, and radiation dose management.
April 9, 2014
2014 04 09 16 01 16 245 Dollar Bandaid 200
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