Regulatory: Page 103

Calgary Scientific receives another FDA clearance
By AuntMinnie.com staff writers
Calgary Scientific has received class II clearance from the U.S. Food and Drug Administration for its ResolutionMD software for mobile diagnostic use on all imaging modalities except for mammography.
April 6, 2014
HHS proposes new HIT software regulation
By AuntMinnie.com staff writers
The U.S. Department of Health and Human Services (HHS) on Thursday released a report that recommends a new regulatory framework for healthcare IT software.
April 2, 2014
Theraclion's Echopulse wins IDE from FDA
By AuntMinnie.com staff writers
Theraclion has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration for its Echopulse high-intensity focused ultrasound device.
April 2, 2014
President Obama signs SGR patch into law
By AuntMinnie.com staff writers
President Barack Obama signed into law on April 1 a 12-month patch for the sustainable growth rate (SGR) formula, the White House said.
April 2, 2014
FDA clears Siemens flat-panel mobile C-arm
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared a new mobile C-arm from Siemens Healthcare that is outfitted with a flat-panel digital detector.
April 1, 2014
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
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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
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