Regulatory: Page 109

NRC accepts 2nd part of Shine's isotope permit application
By AuntMinnie.com staff writers
The U.S. Nuclear Regulatory Commission (NRC) has accepted the second part of Shine Medical Technologies' construction permit application.
December 3, 2013
CMS may change imaging equipment maintenance directive
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) may modify its maintenance directive for medical imaging and radiation therapy equipment in hospitals.
December 2, 2013
Fuji gets FDA OK for pediatric DR detectors
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received 510(k) clearance from the U.S Food and Drug Administration (FDA) for its gadolinium and cesium digital radiography (DR) detectors for pediatric use.
December 2, 2013
TomTec gets FDA clearance for imaging software
By AuntMinnie.com staff writers
TomTec Imaging Systems has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TomTec-Arena software.
December 2, 2013
Not much to be thankful for in final 2014 MPFS, OPPS rules
By Kate Madden Yee
There's not a lot for medical imaging to be thankful for in the new Medicare payment rates for 2014. On November 27, the U.S. Centers for Medicare and Medicaid Services revealed its estimate of next year's physician payment cut under the sustainable growth rate formula.
November 28, 2013
Elekta gets FDA clearance for Monaco 5
By AuntMinnie.com staff writers
Radiation oncology firm Elekta has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Monaco 5 radiation therapy treatment planning systems.
November 26, 2013
CMC lands Orphan Drug Designation by FDA
By AuntMinnie.com staff writers
Swedish contrast media developer CMC Contrast has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its CMC-001 liver-specific contrast agent.
November 26, 2013
IBA secures FDA clearance for imaging software suite
By AuntMinnie.com staff writers
Radiopharmaceutical provider Ion Beam Applications has received U.S. Food and Drug Administration (FDA) clearance for its adaPT Insight imaging software suite.
November 26, 2013
CIVCO's EX3 Stepper gets FDA OK
By AuntMinnie.com staff writers
CIVCO Medical Solutions now can market its EX3 Stepper low-dose-rate and high-dose-rate ultrasound-guided brachytherapy system.
November 20, 2013
FDA warns of risks with Lexiscan, Adenoscan stress agents
By Wayne Forrest
The U.S. Food and Drug Administration on November 20 issued a warning about a "rare but serious risk of heart attack and death" with the use of two cardiac nuclear stress test agents made by pharmaceutical developer Astellas.
November 19, 2013
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House subcommittee mulls new approach to mobile app regulation
By Erik L. Ridley
The debate over how best to regulate mobile medical apps reached the halls of the U.S. Congress this week as representatives sparred over a proposed bill that could strip the U.S. Food and Drug Administration of its authority to regulate many types of app software.
November 19, 2013
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USPSTF to review breast screening guidelines
By AuntMinnie.com staff writers
The U.S. Preventive Services Task Force (USPSTF) has begun a review of its guidelines on breast cancer screening -- perhaps opening up a replay of its controversial 2009 decision rescinding support for screening younger women.
November 13, 2013
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