Regulatory: Page 78

USPSTF opens review of osteoporosis screening
By AuntMinnie.com staff writers
The U.S. Preventive Services Task Force (USPSTF) has opened a review of the effectiveness of screening for osteoporosis.
June 18, 2015
House passes repeal of medical device excise tax
By AuntMinnie.com staff writers
In a 280 to 140 vote, the U.S. House of Representatives has passed the Protect Medical Innovation Act (HR 160), which would repeal the 2.3% medical device excise tax.
June 18, 2015
FDA clears Agfa's Xero mobile image viewer
By AuntMinnie.com staff writers
Agfa HealthCare has received 510(k) clearance from the U.S. Food and Drug Administration for its Xero mobile viewer for diagnostic viewing.
June 17, 2015
FDA classifies Cellectar agent as combination product
By AuntMinnie.com staff writers
Cellectar Biosciences said the U.S. Food and Drug Administration has determined that its CLR1502 tumor margin illumination agent will be evaluated as a combination product and assigned to the Center for Devices and Radiological Health.
June 11, 2015
VA probe refutes charges of MRI records purge
By AuntMinnie.com staff writers
An investigation by the U.S. Department of Veterans Affairs (VA) Office of Inspector General has found no evidence of a mass purge of records regarding MRI exam requests at a VA facility in Los Angeles.
June 11, 2015
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
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