Regulatory: Page 229

Varian gets FDA OK for RPM feature
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems of Palo Alto, CA, has received U.S. Food and Drug Administration 510(k) clearance for patient position monitoring capabilities for its RPM respiratory gating system.
January 29, 2007
ev3 gets FDA approval for Protege RX
By AuntMinnie.com staff writers
Interventional device firm ev3 of Plymouth, MN, has received U.S. Food and Drug Administration approval for its Protege RX carotid stent.
January 24, 2007
NovaRad gets mammo clearance
By AuntMinnie.com staff writers
PACS vendor NovaRad has received U.S. Food and Drug Administration clearance for reading and interpreting mammography studies on its NovaPACS product.
January 23, 2007
FlowCardia receives recanalization 510(k)
By AuntMinnie.com staff writers
Endovascular device developer FlowCardia said that it has received U.S. Food and Drug Administration 510(k) clearance for its Crosser 14 chronic total occlusion (CTO) recanalization system.
January 22, 2007
FDA OKs longer shelf life for Taxus
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific said that the U.S. Food and Drug Administration has approved extending the shelf life of its Taxus Express² paclitaxel-eluting coronary stent system from 12 months to 18 months.
January 17, 2007
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
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