Regulatory: Page 79

FDA issues adverse MQSA report for ND hospital
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has posted an adverse event report for a North Dakota hospital's mammography performance.
June 10, 2015
Lumicell gets FDA nod for breast surgery imaging trial
By AuntMinnie.com staff writers
Image-guidance firm Lumicell has received an investigational device exemption from the U.S. Food and Drug Administration allowing it to launch a pilot study for intraoperative imaging of breast cancer during surgery.
June 4, 2015
FDA posts guidance on MQSA regulation of DBT units
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has posted a frequently asked questions page on its website regarding digital breast tomosynthesis (DBT) and Mammography Quality Standards Act (MQSA) training requirements.
June 3, 2015
Rivanna lands FDA nod for Accuro navigation
By AuntMinnie.com staff writers
Rivanna Medical has received U.S. Food and Drug Administration 510(k) clearance for Accuro, an ultrasound device designed to provide 3D navigation guidance for clinicians using needles or probes.
June 3, 2015
Piramal wins Korean approval of Neuraceq radiotracer
By AuntMinnie.com staff writers
Radiopharmaceutical imaging developer Piramal Imaging and partner Ci-Co Healthcare have received marketing approval in South Korea for Piramal's Neuraceq radiotracer.
June 2, 2015
Carestream gets FDA nod for ultrasound systems
By AuntMinnie.com staff writers
Carestream Health has received U.S. Food and Drug Administration 510(k) clearance for its Touch Prime and Touch Prime XE premium ultrasound scanners.
June 1, 2015
MITA issues paper on XR-29 compliance
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) has issued a white paper designed to help healthcare facilities that operate CT scanners achieve compliance with the XR-29 radiation dose reduction standard, also known as MITA Smart Dose CT.
May 31, 2015
Toshiba gets FDA nod for 3T MRI upgrades
By AuntMinnie.com staff writers
Toshiba America Medical Systems has received U.S. Food and Drug Administration clearance for a package of hardware and software upgrades for its Vantage Titan 3T MRI scanner.
May 28, 2015
SuperSonic wins Japanese regulatory approval
By AuntMinnie.com staff writers
SuperSonic Imagine has received regulatory approval in Japan for its most recent Aixplorer ultrasound scanner.
May 28, 2015
House panel confirms bill that includes MPPR repeal
By AuntMinnie.com staff writers
The Energy and Commerce Committee of the U.S. House of Representatives has unanimously confirmed legislation that includes a repeal of the 25% payment cut to the Medicare Physician Fee Schedule that is mandated by the Multiple Procedure Payment Reduction (MPPR).
May 21, 2015
FDA OKs new Visage app
By AuntMinnie.com staff writers
Visage Imaging has received U.S. Food and Drug Administration clearance for Visage Ease Pro for mobile diagnostic interpretation of all imaging modalities except mammography.
May 18, 2015
USPSTF mammo recs would cut coverage for 17M women
By Kate Madden Yee
If the most recent U.S. Preventive Services Task Force (USPSTF) breast cancer screening guidelines are finalized, 17 million women between the ages of 40 and 49 could lose insurance coverage for mammography screening exams, according to a new report released by consulting firm Avalere Health.
May 13, 2015
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