Regulatory: Page 231

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
Medicsight launches ColonCAR software
By AuntMinnie.com staff writers
Computer-aided detection firm Medicsight has released its image analysis software tool for virtual colonoscopy, ColonCAR (Computer-Assisted Reader) 1.2.1.
November 26, 2006
Spectrum Dynamics receives 510(k) for D-SPECT
By AuntMinnie.com staff writers
Israeli gamma camera developer Spectrum Dynamics of Tirat Hacarmel has received clearance from the U.S. Food and Drug Administration for its D-SPECT cardiac system with BroadView imaging technology.
November 26, 2006
Alara gets FDA clearance for CRystalView R200
By AuntMinnie.com staff writers
Computed radiography (CR) developer Alara has received U.S. Food and Drug Administration clearance for its CRystalView R200 desktop CR system for general radiography applications.
November 26, 2006
Amicas nets 510(k) for Vision Series 5
By AuntMinnie.com staff writers
PACS vendor Amicas reported that it has received U.S. Food and Drug Administration clearance to perform primary interpretation of digital mammography on its Vision Series PACS, version 5.0.
November 21, 2006
IMCO submits IMCO-Stat to FDA
By AuntMinnie.com staff writers
PACS vendor IMCO Technologies of Pewaukee, WI, has submitted its IMCO-Stat communications technology software to the U.S. Food and Drug Administration for review and clearance.
November 19, 2006
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