Regulatory: Page 218

Fuji gets nod for Unity SpeedSuite
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received U.S. Food and Drug Administration (FDA) clearance for its Unity SpeedSuite digital radiography system.
February 28, 2008
Covidien gets tentative nod for generic sestamibi
By AuntMinnie.com staff writers
Covidien has received tentative approval from the U.S. Food and Drug Administration (FDA) for a generic version of the Cardiolite technetium sestamibi radiopharmaceutical for myocardial perfusion studies.
February 26, 2008
NEC gets OK for 5-MP display
By AuntMinnie.com staff writers
NEC Display Solutions of America of Itasca, IL, has received U.S. regulatory clearance to market a 5-megapixel display for medical applications.
February 24, 2008
3mensio wins FDA clearance for vascular imaging package
By AuntMinnie.com staff writers
Advanced visualization developer 3mensio Medical Imaging of Bilthoven, Netherlands, has received clearance from the U.S. Food and Drug Administration (FDA) for its 3surgery Vascular Imaging software, the company reported.
February 24, 2008
Siemens scores FDA OK for molecular system
By AuntMinnie.com staff writers
Siemens Medical Solutions has received U.S. Food and Drug Administration (FDA) clearance for its Versant 440 molecular system for use with Versant HCV RNA 3.0 assay for the management of patients with the hepatitis C virus (HCV) who are undergoing antiviral therapy.
February 18, 2008
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
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