Regulatory: Page 211

Covidien launches generic Cardiolite
By AuntMinnie.com staff writers
Radiopharmaceutical firm Covidien has launched a generic version of Cardiolite, the technetium sestamibi radiopharmaceutical for SPECT myocardial perfusion imaging.
September 22, 2008
Digirad gets FDA nod for nSpeed
By AuntMinnie.com staff writers
Nuclear medicine vendor Digirad has received U.S. Food and Drug Administration 510(k) clearance for its nSpeed reconstruction software.
September 22, 2008
FDA clears GE's AdreView imaging agent
By AuntMinnie.com staff writers
GE Healthcare has received clearance from the U.S. Food and Drug Administration to market its AdreView (iobenguane I-123 injection) molecular imaging agent for the detection of rare neuroendocrine tumors in children and adults.
September 18, 2008
Kjaya Medical wins FDA clearance for VoXcell
By AuntMinnie.com staff writers
Medical graphics computing technology firm Kjaya Medical has received clearance from the U.S. Food and Drug Administration for its next-generation thin-client image distribution and visualization package.
September 17, 2008
FDA updates ultrasound equipment guidance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has updated its guidance for manufacturers seeking marketing clearance for diagnostic ultrasound systems.
September 17, 2008
FDA clears Siemens Ysio wireless DR
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared Ysio, a new Siemens Healthcare wireless digital radiography (DR) system.
September 8, 2008
Hologic gets FDA nod for FRAX
By AuntMinnie.com staff writers
Women's imaging firm Hologic has received U.S. Food and Drug Administration 510(k) clearance to incorporate the World Health Organization's 10-year fracture risk calculator (FRAX) into its bone densitometry systems.
September 8, 2008
Definity echo contrast agent lands on FDA drug safety list
By Brian Casey
Executives at Lantheus Medical Imaging say they are surprised that the U.S. Food and Drug Administration has included the company's Definity echocardiography contrast agent on a list of pharmaceuticals being evaluated for safety issues.
September 7, 2008
TomoTherapy gets 510(k) for new Hi-Art mode
By AuntMinnie.com staff writers
Radiation therapy firm TomoTherapy said it has received U.S. Food and Drug Administration clearance for TomoDirect, a new mode for its Hi-Art radiation therapy system.
August 26, 2008
AMAG MRI agent gets fast-track status
By AuntMinnie.com staff writers
MRI contrast developer AMAG Pharmaceuticals has received fast-track status from the U.S. Food and Drug Administration for a regulatory application for its ferumoxytol imaging agent.
August 24, 2008
CMS gets 510(k) for segmentation software
By AuntMinnie.com staff writers
Radiation therapy planning firm CMS has received U.S. Food and Drug Administration 510(k) clearance for its Atlas-Based Autosegmentation (ABAS) software.
August 21, 2008
FDA releases MRI implant guidance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has released a new guidance document covering the use of passive implants in MRI environments.
August 21, 2008
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