Regulatory: Page 125

FDA approves new Definity manufacturing site
By AuntMinnie.com staff writers
Diagnostic imaging agent developer Lantheus Medical Imaging has received approval from the U.S. Food and Drug Administration for Jubilant HollisterStier to be a new manufacturing site for its Definity ultrasound contrast imaging agent .
February 10, 2013
Planmed gets FDA clearance for extremity CT scanner
By AuntMinnie.com staff writers
Finnish imaging vendor Planmed said it has received U.S. Food and Drug Administration clearance for its Verity extremity scanner.
February 10, 2013
Kids get their own EHR format
By AuntMinnie.com staff writers
Pediatric patients are now getting their own electronic health record (EHR) format with children-specific data elements, thanks to a new initiative from the U.S. Department of Health and Human Services' Agency for Healthcare Research and Quality and the Centers for Medicare and Medicaid Services.
February 7, 2013
2nd bill to replace device tax is introduced
By AuntMinnie.com staff writers
A second bill to repeal the 2.3% medical device tax has been introduced into Congress.
February 7, 2013
SGR repeal bill debuts in House
By AuntMinnie.com staff writers
Legislation that would permanently repeal Medicare's sustainable growth rate (SGR) formula has been introduced in the U.S. House of Representatives by Rep. Allyson Schwartz (D-PA) and Rep. Joe Heck (R-NV).
February 6, 2013
AMIC submits RadioGel data to FDA
By AuntMinnie.com staff writers
Medical isotope producer Advanced Medical Isotope (AMIC) has submitted data on its RadioGel device to the U.S. Food and Drug Administration and requested a collaborative meeting.
February 6, 2013
FDA issues Alzheimer's treatment guidelines
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration on February 7 issued a proposal designed to assist companies that are developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of overt dementia.
February 6, 2013
Audit cites irregularities in University of Ark. rad department
By AuntMinnie.com staff writers
An audit of the University of Arkansas for Medical Sciences' radiology department found irregularities in the department's moonlighting protocol compliance and in payments from outside entities, according to the January 16 report.
February 5, 2013
Bill introduced to repeal medical device tax
By AuntMinnie.com staff writers
Rep. Erik Paulsen (R-MN) and Rep. Ron Kind (D-WI) on February 6 introduced HR 523, the Protect Medical Innovation Act, which is aimed at repealing the 2.3% excise tax on medical devices.
February 5, 2013
Resonance Health's FerriScan R2-MRI gets FDA OK
By AuntMinnie.com staff writers
Imaging laboratory services provider Resonance Health announced that the U.S. Food and Drug Administration (FDA) has given the company permission to market its FerriScan R2-MRI device as an imaging companion diagnostic device in the use of Exjade pharmaceutical therapy.
February 3, 2013
MITA backs coverage for beta-amyloid PET
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) is encouraging the U.S. Centers for Medicare and Medicaid Services to consider diagnostic end points as the basis for its coverage of beta-amyloid imaging.
January 31, 2013
Digirad nets additional FDA clearance for ergo
By AuntMinnie.com staff writers
Nuclear medicine firm Digirad has received U.S. Food and Drug Administration 510(k) clearance for new applications on its ergo imaging general-purpose nuclear medicine camera.
January 31, 2013
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