Regulatory: Page 127

USPSTF to revisit carotid artery stenosis screening
By AuntMinnie.com staff writers
The U.S. Preventive Services Task Force (USPSTF) plans to review its guidelines on the use of imaging to screen patients for asymptomatic carotid artery stenosis.
January 15, 2013
GE files sNDA to manufacture Optison
By AuntMinnie.com staff writers
GE Healthcare has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration that would allow the company to manufacture its Optison ultrasound contrast agent at its own manufacturing facility.
January 14, 2013
Viztek lands FDA nod for DR panels
By AuntMinnie.com staff writers
Imaging informatics firm Viztek has received U.S. Food and Drug Administration 510(k) clearance for its ViZion + DR line of digital radiography (DR) panels.
January 14, 2013
InfoGard receives ONC authorization
By AuntMinnie.com staff writers
Information assurance and security company InfoGard Laboratories has been authorized as a U.S. Office of the National Coordinator Authorized Testing and Certification Body (ONC-ATCB).
January 14, 2013
CMS issues new meaningful use guidance
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has provided new guidance that clarifies the eligibility of certain radiologists for the "significant hardship" exception added in stage 2 of its meaningful use IT incentive program.
January 9, 2013
Riverain gets 510(k) for device placement software
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared new software from Riverain Technologies that improves the clarity of conventional chest x-ray images and allows radiologists to confirm the proper placement of medical devices, according to the company.
January 8, 2013
GE files applications for F-18 flutemetamol
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration and the European Medicines Agency have accepted applications from GE Healthcare for review of its investigational F-18 flutemetamol PET amyloid imaging agent.
January 7, 2013
Most radiologists don't meet Medicare quality reporting rules
By Kate Madden Yee
More than three-quarters of radiologists are not meeting requirements of the Medicare Physician Quality Reporting System, according to a study to be published in the February issue of the Journal of the American College of Radiology. The shortfall could expose radiologists to penalties starting in 2015.
January 7, 2013
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FDA gives OK to Elekta Mosaiq software
By AuntMinnie.com staff writers
Radiation oncology firm Elekta announced that Mosaiq Evaluate, a toolset that integrates radiation therapy treatment planning features into its Mosaiq oncology information system, has received 510(k) clearance from the U.S. Food and Drug Administration.
January 7, 2013
iCAD receives nod from FDA
By AuntMinnie.com staff writers
Computer-aided detection (CAD) firm iCAD said it has received U.S. Food and Drug Administration clearance for its PowerLook Advanced Mammography Platform (AMP) software with digital CAD, to be used with Philips Healthcare's MicroDose full-field digital mammography system.
January 6, 2013
Obama signs 'fiscal cliff' legislation
By AuntMinnie.com staff writers
President Barack Obama late Wednesday signed the American Taxpayer Relief Act (ATRA) of 2012, legislation that resolves the "fiscal cliff" impasse but also includes significant Medicare reimbursement cuts to radiology and radiation oncology services.
January 2, 2013
ASTRO decries rad therapy cuts in 'fiscal cliff' bill
By AuntMinnie.com staff writers
The American Society for Radiation Oncology (ASTRO) has issued a statement opposing Medicare payment cuts to cobalt-60 radiation therapy treatments in the American Taxpayer Relief Act of 2012, the legislation passed this week that resolved the "fiscal cliff" emergency.
January 2, 2013
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