Regulatory: Page 230

Epix files U.S. Vasovist appeal
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals of Lexington, MA, said it will submit a formal appeal to the director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA).
December 14, 2006
Boston Scientific receives FDA nod for FilterWire EZ
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has received clearance from the U.S. Food and Drug Administration (FDA) to market its FilterWire EZ embolic protection system for use in carotid artery stenting (CAS) procedures.
December 13, 2006
ART gets Health Canada approval for SoftScan
By AuntMinnie.com staff writers
Canadian optical molecular imaging developer ART Advanced Research Technologies (ART) reported that it has received clearance from Health Canada to commercialize its SoftScan optical breast imaging device.
December 13, 2006
Novadaq gets Canadian approval for Luna
By AuntMinnie.com staff writers
Novadaq Technologies reported that it has received Health Canada approval for use of its Luna surgical visualization system for urological procedures.
December 11, 2006
Advanced Magnetics, Guerbet file for European clearance of Combidex
By AuntMinnie.com staff writers
MRI contrast developer Advanced Magnetics said that its European partner Guerbet has filed a marketing authorization application (MAA) with the European Agency for the Evaluation of Medicinal Products (EMEA) for its Combidex functional MRI agent.
December 5, 2006
Aurora gets breast MRI clearance from China
By AuntMinnie.com staff writers
Breast MRI technology developer Aurora Imaging Technology has received a registration certificate for its 1.5-tesla dedicated breast MRI system from the State Food and Drug Administration (SFDA) of the People's Republic of China.
December 5, 2006
VirtualScopics gets patent
By AuntMinnie.com staff writers
Computerized image analysis developer VirtualScopics of Rochester, NY, has been issued a patent from the U.S. Patent Office for the method and use of automatically identifying and quantifying abnormal anatomical structures found in medical images.
November 29, 2006
FDA clears Siemens' syngo applications
By AuntMinnie.com staff writers
Siemens Medical Solutions of Malvern, PA, has received 510(k) clearance from the U.S. Food and Drug Administration for the first of many syngo dual-energy applications for its dual-source Somatom Definition CT system.
November 27, 2006
AngioDynamics gets clearance for soft-tissue ablation technology
By AuntMinnie.com staff writers
Interventional technology provider AngioDynamics of Queensbury, NY, announced that the U.S. Food and Drug Administration has given clearance for its soon-to-be subsidiary, Oncobionic, to market Irreversible Electroporation (IRE), a technology that allows for surgical ablation of soft tissue, including cardiac and smooth muscle.
November 27, 2006
Toshiba gets FDA clearance for Vantage Atlas MRI
By AuntMinnie.com staff writers
Toshiba America Medical Systems announced it has received U.S. Food and Drug Administration clearance for its Excelart Vantage Atlas MRI system.
November 27, 2006
IDSI forms Italian CT laser mammography firm
By AuntMinnie.com staff writers
CT laser mammography (CTLM) developer Imaging Diagnostic Systems (IDSI) has inked a multiyear distribution deal with CTLM Italia, a new company established to market IDSI's CTLM imaging system in Italy.
November 26, 2006
E-Z-EM receives FDA OK for EmpowerSync
By AuntMinnie.com staff writers
Contrast and virtual colonoscopy accessory developer E-Z-EM announced that it has received clearance from the U.S. Food and Drug Administration for its EmpowerSync injector sychronization system.
November 26, 2006
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