Regulatory: Page 230

Neoprobe gets FDA nod for more Lymphoseek trials
By AuntMinnie.com staff writers
Gamma camera probe developer Neoprobe has received authorization from the U.S. Food and Drug Administration (FDA) to begin patient enrollment in two phase I clinical studies for its Lymphoseek targeting agent.
January 16, 2007
GE halts surgical C-arm sales due to FDA concerns
By AuntMinnie.com staff writers
GE Healthcare has halted the manufacturing and distribution of surgical C-arms after the U.S. Food and Drug Administration (FDA) expressed concerns over current good manufacturing practices (CGMPs) at the facilities where the systems are made.
January 15, 2007
Viztek gets FDA nod
By AuntMinnie.com staff writers
Imaging informatics firm and medical imaging device reseller Viztek has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its OpalRad integrated RIS/PACS network.
January 2, 2007
ICD-9-CM 2007 changes: What and why
On October 1, 2006, there were 234 new International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis codes, 29 invalid codes, and more than 100 revised code descriptions that became effective. Deepa Malhotra of Health Care Educational Resource Services walks you through the changes, which offer more detailed information about certain disease processes.
January 1, 2007
FDA learns of more cases of gadolinium-related disease
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has updated its advisory on using gadolinium-based MRI contrast agents in patients with moderate to end-stage kidney failure, after receiving additional reports of patients who developed a rare disease following gadolinium administration.
December 25, 2006
Kodak files for Canadian OK of CR mammo system
By AuntMinnie.com staff writers
Eastman Kodak Health Group of Rochester, NY, has filed an application with Health Canada for regulatory clearance of its computed radiography (CR) system for mammography.
December 18, 2006
IMCO gets FDA nod for IMCO-Stat
By AuntMinnie.com staff writers
PACS vendor IMCO Technologies has received U.S. Food and Drug Administration (FDA) clearance for its IMCO-Stat wireless communication software.
December 17, 2006
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
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