Regulatory: Page 69

FDA OKs CT contrast agents from Bracco
By AuntMinnie.com staff writers
Contrast developer Bracco Diagnostics announced that the U.S. Food and Drug Administration (FDA) has approved a new drug application for two contrast agents to be used in CT of the abdomen.
February 21, 2016
FDA clears ScandiDos dosimetry system
By AuntMinnie.com staff writers
Radiation therapy quality assurance firm ScandiDos has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Delta4 Discover in vivo dosimetry system.
February 18, 2016
Fuji gets FDA nod for Synapse 5 PACS
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Synapse 5 PACS software.
February 17, 2016
Clear Guide lands FDA nod for ultrasound/CT fusion unit
By AuntMinnie.com staff writers
Johns Hopkins University spin-off Clear Guide Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Scenergy ultrasound/CT fusion and image guidance technology.
February 15, 2016
Obama proposes bigger cancer budget for 2017
By AuntMinnie.com staff writers
President Obama's 2017 budget, released on Monday, proposes $5.9 billion to support biomedical research, an increase of $680 million or 13% from the previous year, according to the American Society for Radiation Oncology, which lauded the proposal.
February 11, 2016
AMIC warns of prior authorization threat
By AuntMinnie.com staff writers
The Access to Medical Imaging Coalition (AMIC) is speaking out against provisions calling for the use of prior authorization for fee-for-service imaging procedures paid for by Medicare that were included in President Obama's proposed 2017 budget.
February 10, 2016
FDA releases draft guidance for radiology displays
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has released a new draft guidance for display devices used in diagnostic radiology.
February 10, 2016
Medicare to cut analog x-ray payments starting in 2017
By Brian Casey
As part of a push to nudge U.S. healthcare providers to adopt digital radiography, the Medicare system will begin reducing payments for exams performed on analog x-ray systems starting in 2017. The year after that, sites using computed radiography equipment will also see payment reductions.
February 7, 2016
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10 states introduced breast density laws this year
By AuntMinnie.com staff writers
The Are You Dense Advocacy group announced that 10 states have joined its grass-roots efforts to ensure that women are informed of their breast density status if they are found to have dense tissue at mammography.
January 31, 2016
CMS, ONC officials preview new EHR incentive program
By Erik L. Ridley
Though existing meaningful use regulations still remain in effect, the U.S. government plans to propose new regulations in the spring that will detail how the electronic health record (EHR) incentive program will transition to align with recent initiatives promoting value-based care.
January 20, 2016
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FDA provides guidance on mammo equipment QC
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a reminder to mammography facilities that they must use qualified medical physicists to survey their equipment, oversee equipment-related quality control (QC) programs, and perform mammography equipment evaluations.
January 20, 2016
FDA releases new cybersecurity recommendations
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has published a draft guidance to aid medical device manufacturers in postmarket management of device cybersecurity.
January 17, 2016
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