Regulatory: Page 92

JAMA IM editorials weigh in on lung cancer screening
By Eric Barnes
With Medicare on the cusp of a momentous decision about whether to pay for CT lung cancer screening, the issue is the focus of a pair of editorials published October 13 in JAMA Internal Medicine. Taking opposite sides, the articles one last time outline positions that have become solidified as the U.S. government weighs what could be one of the biggest public health initiatives in decades.
October 12, 2014
Bracco gets FDA nod for ultrasound contrast agent
By Erik L. Ridley
A third contestant has joined the U.S. market for ultrasound contrast agents: On Friday, Bracco Diagnostics received U.S. Food and Drug Administration approval for its Lumason ultrasound contrast agent. The approval marks the end of a long odyssey for Bracco in its efforts to bring the agent to market.
October 9, 2014
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FDA clears tumor segmentation software
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared tumor segmentation software developed by Columbia University and licensed to Varian Medical Systems.
October 9, 2014
Kubtec gets FDA nod for breast specimen tomo
By AuntMinnie.com staff writers
Kubtec has received U.S. Food and Drug Administration clearance for its Mozart with TomoSpec breast specimen radiography and tomosynthesis system.
October 6, 2014
CMS reopens MU hardship exception
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) said it will once again accept hardship exception applications to enable healthcare provides to avoid penalties for not meeting meaningful use (MU) criteria.
October 6, 2014
FDA seeks injunction against ultrasound gel maker
By AuntMinnie.com staff writers
Fearing infections from poor packaging practices, the U.S. Food and Drug Administration is seeking a permanent injunction to ban ultrasound gel manufacturer Pharmaceutical Innovations and its chief executive from manufacturing or selling products until they comply with FDA requirements.
October 5, 2014
Koning secures Australian breast CT clearance
By AuntMinnie.com staff writers
Koning has received the Australian Register of Therapeutic Goods Certificate for its Koning Breast CT system and biopsy add-on option.
October 2, 2014
FDA clears Esaote's MyLab Gamma ultrasound unit
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared ultrasound vendor Esaote North America's MyLab Gamma ultrasound scanner.
October 1, 2014
FDA releases device cybersecurity guidance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has finalized its vendor guidance for the management of cybersecurity in medical devices.
October 1, 2014
FDA: 3D breast imaging demands 3D display
By AuntMinnie.com staff writers
New imaging technologies such as 3D mammography are changing how doctors find and diagnose disease. But they're also sparking the need for display technology that allows images to be viewed in 3D, according to the U.S. Food and Drug Administration.
September 30, 2014
MindwaysCT gets 510(k) for bone density software
By AuntMinnie.com staff writers
MindwaysCT has received 510(k) clearance from the U.S. Food and Drug Administration to market a new version of its software that acquires bone mineral density measurements from CT images.
September 30, 2014
FDA reopens comments on social media rules
By AuntMinnie.com staff writers
Responding to requests for additional time, the U.S. Food and Drug Administration has reopened the comment period for two draft guidances on the use of social media in connection with medical devices and drugs.
September 25, 2014
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