Regulatory: Page 94

Siemens submits PMA for breast tomosynthesis
By AuntMinnie.com staff writers
Siemens Healthcare has submitted a premarket approval application (PMA) to the U.S. Food and Drug Administration for its Mammomat Inspiration mammography system with a digital breast tomosynthesis option.
June 25, 2014
FDA clears Mobius 3D software
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared Mobius Medical Systems' 3D software.
June 25, 2014
Fuji gets FDA nod for digital mammo
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received U.S. Food and Drug Administration 510(k) clearance for its Aspire Cristalle digital mammography system, already commercialized in Europe and Asia.
June 25, 2014
GE's Vivid cardio US scanner gets FDA clearance
By AuntMinnie.com staff writers
GE Healthcare has received U.S. Food and Drug Administration 510(k) clearance for its new Vivid T8 cardiovascular ultrasound scanner.
June 24, 2014
Lung cancer screening of seniors: Should CMS regulate?
By Eric Barnes
A just-published proposal in the Annals of Internal Medicine seeks to balance the benefits and harms of CT lung cancer screening by limiting the screening of Medicare beneficiaries to lung cancer screening centers that would be accredited based on still-evolving society-based guidelines.
June 23, 2014
2014 06 23 16 48 34 275 Wiener Renda 175
FDA issues warning on Mont. breast center
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has issued a warning regarding mammography quality at a Montana breast imaging center.
June 23, 2014
USPSTF finalizes AAA screening recommendations
By Erik L. Ridley
Adhering mostly to its draft statement published in January, the U.S. Preventive Services Task Force (USPSTF) included no big surprises in its new recommendations in favor of ultrasound screening for abdominal aortic aneurysms (AAAs).
June 23, 2014
Texas technologists oppose licensure removal
By Eric Barnes
The Texas Society of Radiologic Technologists said it opposes a recent move by a commission appointed by the Texas Legislature to eliminate licensure requirements for radiologic technologists.
June 19, 2014
Meaningful use deadline for pay cuts coming up
By AuntMinnie.com staff writers
Most physicians will need to act by July 1 to avoid the 1% payment reduction associated with the Medicare Electronic Health Record Incentive Program in 2015, also known as meaningful use, according to the American College of Radiology.
June 18, 2014
Eizo lands FDA nod for new large-monitor system
By AuntMinnie.com staff writers
Eizo has received U.S. Food and Drug Administration 510(k) clearance for an expansion to its large-monitor system.
June 17, 2014
FDA issues draft social media, Internet guidance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has published two draft guidances for the medical industry on the use of social media and Internet communication for medical devices and prescription drugs.
June 16, 2014
FDA readies new MQSA audits
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration said that on June 23 it will begin an audit of certified mammography facilities that claim a Government Entity exemption under the Mammography Quality Standards Act (MQSA).
June 16, 2014
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