Regulatory: Page 100

Carestream gets FDA nod for bone-removal software
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has given 510(k) clearance to Carestream Health for a bone-suppression software feature for its computed and digital radiography systems.
April 1, 2014
Long-term fix dead, Senate passes 1-year SGR patch
By Kate Madden Yee
With hopes dashed for a permanent fix, on March 31 the U.S. Senate, by a vote of 64 to 35, cleared legislation passed by the U.S. House of Representatives to implement a 12-month patch to stave off cuts mandated by the sustainable growth rate (SGR) formula, set to go into effect April 1.
March 31, 2014
2014 02 26 18 14 31 705 Capitol Hill 200
Analogic receives FDA clearance for needle kit
By AuntMinnie.com staff writers
Analogic has received 510(k) clearance from the U.S. Food and Drug Administration for its SonixGPS nerve block needle kit.
March 30, 2014
House passes 12-month SGR patch
By AuntMinnie.com staff writers
Just weeks after bipartisan legislation to permanently repeal the sustainable growth rate (SGR) formula stalled in Congress, the U.S. House of Representatives has passed by voice vote HR 4302, the Protecting Access to Medicare Act of 2014, which prevents a 24% cut to Medicare physician reimbursement rates that would go into effect on April 1.
March 26, 2014
Accuray wins approval to market CyberKnife in Japan
By AuntMinnie.com staff writers
Accuray has received approval from the Japanese Ministry of Health, Labor, and Welfare to market its CyberKnife M6 radiation therapy system.
March 26, 2014
Calif. Senate bill would strike down in-office exception
By AuntMinnie.com staff writers
A bill introduced in February in the California Senate was amended on March 26 to eliminate the in-office exception for advanced imaging and radiation oncology from the state's self-referral regulations.
March 26, 2014
FDA: Radiology device recalls skyrocketed after 2010
By Brian Casey
The number of radiology devices recalled by the U.S. Food and Drug Administration skyrocketed after 2010 due to concerns over patient exposure to radiation following several high-profile radiation accidents.
March 26, 2014
2013 09 06 11 46 32 375 Fda Logo 200
House introduces yet another SGR patch
By Kate Madden Yee
With bipartisan efforts stalled for a permanent repeal of the sustainable growth rate (SGR) formula, two committees in the U.S. House of Representatives have introduced yet another patch that would avert cuts to Medicare reimbursement mandated by the SGR.
March 25, 2014
2014 02 26 18 14 31 705 Capitol Hill 200
Shimadzu gets FDA nod for Trinias angio system
By AuntMinnie.com staff writers
Shimadzu Medical Systems USA has received U.S. Food and Drug Administration 510(k) clearance for Trinias, its new family of digital angiography systems.
March 24, 2014
Redberg editorial calls for tighter device approvals
By AuntMinnie.com staff writers
Dr. Rita Redberg has co-authored a new editorial charging that the U.S. Food and Drug Administration should require new clinical trials for changes made to high-risk devices that have already been approved.
March 24, 2014
CMS hones in on CT lung screening questions for advisory meeting
By Eric Barnes
The U.S. Centers for Medicare and Medicaid Services (CMS) has published additional details about the discussion topics it plans to address in an April 30 advisory committee meeting on reimbursement for CT lung cancer screening.
March 23, 2014
FDA OKs Piramal's Neuraceq PET agent
By AuntMinnie.com staff writers
Piramal Imaging has received U.S. Food and Drug Administration approval for its Neuraceq PET imaging agent.
March 20, 2014
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