Regulatory: Page 109

FDA finalizes new UDI system to identify devices
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration on September 20 issued a final rule that implements its unique device identification (UDI) system.
September 19, 2013
MITA lauds Senate passage of helium bill
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) said it supports the U.S. Senate passage of legislation to keep the Federal Helium Reserve open.
September 19, 2013
GE touts ABUS study
By AuntMinnie.com staff writers
GE Healthcare is pointing to a recent study that showed that radiologists using automated breast ultrasound (ABUS) had high interreader agreement.
September 19, 2013
CMS: U.S. healthcare spending to rebound after 2014
By Kate Madden Yee
Healthcare spending in the U.S. is expected to rebound between 2014 and 2022 to growth rates seen prior to the recent economic slowdown. Rates will be higher than in the recent past but lower compared to longer-term historical growth, according to a report published online September 18 in Health Affairs.
September 17, 2013
Matakina registers VolparaAnalytics with FDA
By AuntMinnie.com staff writers
Breast imaging software developer Matakina International announced registration of its new class I software medical device, VolparaAnalytics, with the U.S. Food and Drug Administration.
September 17, 2013
Fla. radiation oncologists pay $3.5M settlement
By AuntMinnie.com staff writers
Two radiation oncologists in Pensacola, FL, will pay $3.5 million to the government and the state of Florida to resolve Medicare fraud allegations, according to the U.S. Department of Justice.
September 17, 2013
CBO: House SGR fix comes with 26% higher price tag
By Kate Madden Yee
A bill passed in August out of a U.S. House of Representatives committee that would repeal the Medicare sustainable growth rate (SGR) formula may soon hit another obstacle as it proceeds on its legislative journey: a higher price tag.
September 15, 2013
MITA, NEMA urge helium bill passage
By AuntMinnie.com staff writers
A coalition of technology, medical, business, and education groups are urging the U.S. Congress to pass legislation that will secure the nation's helium supply.
September 11, 2013
InSightec launches ExAblate trial
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec has treated the first patient for essential tremor in a phase III clinical trial of its ExAblate Neuro system.
September 9, 2013
Canadian proposal would ban private MRI, CT scans
By AuntMinnie.com staff writers
The College of Physicians and Surgeons of Alberta is seeking to bar privately paid MRI and CT scans because they allow patients who can afford the tests to jump the line for care, according to a report in the Calgary Herald.
September 9, 2013
FDA panel mostly likes evidence on CTC efficacy
By Eric Barnes
In a wide-ranging session on CT colonography (CTC), held in Silver Spring, MD, on Monday, a panel of experts convened by the U.S. Food and Drug Administration delivered almost universally positive views of the evidence supporting the use of the exam for colorectal cancer screening.
September 9, 2013
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FDA sets meeting to review CT colonography
By Eric Barnes
A virtual who's who of CT colonography (CTC) is en route to the Washington, DC, area for a September 9 joint committee meeting of the U.S. Food and Drug Administration that will discuss the fate of CTC screening for asymptomatic individuals.
September 5, 2013
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