Regulatory: Page 219

Siemens gets FDA OK for zeego, partners with AFRL
By AuntMinnie.com staff writers
Siemens Medical Solutions' Artis zeego angiography system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
February 17, 2008
Joint Commission: MRI accidents increase
By AuntMinnie.com staff writers
The Joint Commission of Oakbrook Terrace, IL, has issued an alert warning that MRI accidents are on the rise, and has urged hospitals and other healthcare facilities to take steps to prevent them.
February 14, 2008
DRTech nets FDA OK for x-ray detector
By AuntMinnie.com staff writers
Flat-panel digital x-ray detector manufacturer DRTech of Seongnam, South Korea, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new detector, Flaatz 750.
February 14, 2008
Siemens responds to FDA warning letter
By AuntMinnie.com staff writers
Siemens Medical Solutions' molecular imaging division has received a warning letter from the U.S. Food and Drug Administration (FDA) regarding the company's molecular imaging equipment, specifically the company's ECAT PET scanner.
February 14, 2008
NRC investigates Covidien production issue
By AuntMinnie.com staff writers
The U.S. Nuclear Regulatory Commission (NRC) said it is working with Mallinckrodt, a division of Covidien of Hamilton, Bermuda, to investigate elevated levels of molybdenum-99 in the company's technetium-99m isotope.
February 7, 2008
PharmaLogic P.E.T. Services receives PET nod
By AuntMinnie.com staff writers
PharmaLogic P.E.T. Services of Montreal has received approval from the Canadian government to begin selling its formulation of FDG.
February 3, 2008
Epix reaches agreement with FDA over Vasovist
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals of Lexington, MA, has reached an agreement with the U.S. Food and Drug Administration (FDA) on a proposal to reread images collected in trials of its blood-pool MR angiography agent, Vasovist, the company reported.
January 31, 2008
CIS-US gets clearance for generic Tc-99m mebrofenin kit
By AuntMinnie.com staff writers
Radiopharmaceutical manufacturer CIS-US has received clearance from the U.S. Food and Drug Administration Office of Generic Drugs to manufacture and market a generic kit for the preparation of technetium-99m (Tc-99m) mebrofenin.
January 29, 2008
Toshiba gets clearance for Titan MRI scanner
By AuntMinnie.com staff writers
Toshiba America Medical Systems has received U.S. Food and Drug Administration clearance for its open-bore 1.5-tesla Vantage Titan MR scanner.
January 27, 2008
Siemens receives FDA nod for Artiste
By AuntMinnie.com staff writers
Siemens Medical Solutions has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Artiste radiation therapy system.
January 23, 2008
ScImage gets FDA nod for digital mammo viewing
By AuntMinnie.com staff writers
PACS vendor ScImage said that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the primary diagnostic review of digital mammography images on its PicomEnterprise PACS offering.
January 22, 2008
FDA extends Cardiolite patent for pediatric use
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has extended the patent on Cardiolite for pediatric applications, effective January 8.
January 21, 2008
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