Regulatory: Page 209

FDA 'concerned' over Acusphere agent
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration said that it has concerns over the safety of an ultrasound contrast agent developed by Acusphere that is currently under regulatory review at the agency.
December 8, 2008
Bard gets FDA nod for vascular stent
By AuntMinnie.com staff writers
Interventional technology developer C. R. Bard has received U.S. Food and Drug Administration clearance to market its E-Luminexx vascular stent.
December 7, 2008
CTLM with mammo boosts breast cancer diagnosis
By AuntMinnie.com staff writers
CT laser mammography (CTLM) system developer Imaging Diagnostic Systems (IDSI) announced that a new study found that its CTLM system increased the accuracy of diagnosing malignant and benign breast lesions when used as an adjunct to mammography.
December 3, 2008
WebMD, FDA partner on health info project
By AuntMinnie.com staff writers
WebMD Health announced a collaboration with the U.S. Food and Drug Administration (FDA) designed to increase consumer's access to the latest FDA information.
December 2, 2008
NEC gets FDA nod for mammography monitor
By AuntMinnie.com staff writers
NEC Display Solutions of America has received U.S. Food and Drug Administration clearance for mammography use of its 5-megapixel MultiSync MD205MG flat-panel monitor.
December 1, 2008
NordicNeuroLab gets FDA nod for fMRI modules
By AuntMinnie.com staff writers
NordicNeuroLab announced that its nordicICE BOLD and DTI Modules used in functional MRI (fMRI) studies have received U.S. Food and Drug Administration 510(k) clearance.
November 30, 2008
QStar gets FDA nod
By AuntMinnie.com staff writers
Storage management firm QStar Technologies has received U.S. Food and Drug Administration 510(k) clearance for its SntryPACS medical imaging archive appliance.
November 25, 2008
Nucletron receives FDA clearance for RT viewer
By AuntMinnie.com staff writers
Radiation oncology firm Nucletron has received clearance from the U.S. Food and Drug Administration for its radiotherapy (RT) viewer.
November 20, 2008
FDA clears Aktina radiotherapy system
By AuntMinnie.com staff writers
Radiation oncology system developer Aktina has received clearance from the U.S. Food and Drug Administration for a new radiation therapy system.
November 20, 2008
Medicsight submits 510(k) for ColonCAD
By AuntMinnie.com staff writers
Computer-aided detection developer Medicsight has filed a 510(k) application to the U.S Food and Drug Administration for its ColonCAD image analysis software.
November 19, 2008
Riverain scores regulatory approvals
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer Riverain Medical has received the European CE Mark and Canadian device licenses for its OnGuard chest x-ray CAD software and SoftView enhanced chest imaging technology.
November 18, 2008
Medtronic gets CE Mark for MRI pacemaker
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has received the European CE Mark for a pacemaker designed for use in MRI systems.
November 16, 2008
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