Regulatory: Page 122

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
CMS committee not yet swayed on brain amyloid PET imaging
By Wayne Forrest
A U.S. Centers for Medicare and Medicaid Services (CMS) advisory committee said on Wednesday that more studies are needed to confirm the efficacy of Eli Lilly and Avid Radiopharmaceuticals' Amyvid radiopharmaceutical for brain beta-amyloid PET imaging.
January 30, 2013
Manufacturer coalition makes 1st device tax payment
By AuntMinnie.com staff writers
A coalition of medical device manufacturers has made a first semimonthly medical device tax payment to the Internal Revenue Service (IRS) of $97 million, a tax that it says is threatening hundreds of thousands of jobs and innovation.
January 29, 2013
FDA offers grants for CDRH radiation protection program
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration will provide grant funds in support of the Center for Devices and Radiological Health (CDRH) 2013 Assuring Radiation Protection program.
January 28, 2013
Augmenix gets FDA clearance for tissue marker
By AuntMinnie.com staff writers
Radiation oncology products developer Augmenix announced that it has received U.S. Food and Drug Administration 510(k) clearance for its TraceIT tissue marker.
January 27, 2013
Varian gets FDA clearances, Algerian order
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received 510(k) clearance from the U.S. Food and Drug Administration for two of the company's products.
January 23, 2013
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