Regulatory: Page 202

Varian gets Acuros clearance
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received 510(k) clearance from the U.S. Food and Drug Administration for its Acuros technology.
July 20, 2009
Pharmalucence gets OK for generic sestamibi
By AuntMinnie.com staff writers
Radiopharmaceutical product supplier Pharmalucence has received U.S. Food and Drug Administration approval to manufacture and market its kit for preparing technetium-99m sestamibi injection.
July 20, 2009
Boston Scientific wins Taxus clearance
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has received clearance from the U.S. Food and Drug Administration for its Taxus Liberté Long paclitaxel-eluting coronary stent system.
July 15, 2009
Nucletron nets FDA OK for new apps
By AuntMinnie.com staff writers
Radiation oncology firm Nucletron has received 510(k) approval from the U.S. Food and Drug Administration for two new applicators for interstitial gynecologic brachytherapy.
July 12, 2009
Mallinckrodt initiates product recall
By AuntMinnie.com staff writers
The Mallinckrodt subsidiary of Covidien has begun a voluntary recall of one lot of its sodium chromate Cr-51 injection product.
July 12, 2009
FDA, Health Canada approve Lantheus moly
By AuntMinnie.com staff writers
Lantheus Medical Imaging has won approval from the U.S. Food and Drug Administration and Health Canada to offer technetium-99m in the U.S. and Canada.
July 8, 2009
Ziosoft gets clearance for cardiac app
By AuntMinnie.com staff writers
Advanced visualization software developer Ziosoft has received U.S. Food and Drug Administration 510(k) clearance for its MR cardiac function analysis application.
July 7, 2009
Covidien gets Canadian OK for generic sestamibi
By AuntMinnie.com staff writers
Healthcare technology firm Covidien has received approval from Health Canada for its generic technetium-99m sestamibi kit.
July 6, 2009
Ziosoft nets CE Mark
By AuntMinnie.com staff writers
Advanced visualization software developer Ziosoft has received the European CE Mark for its Ziostation 3D thin-client software package.
June 30, 2009
FDA clears Hologic mammo software
By AuntMinnie.com staff writers
Women's imaging vendor Hologic has received U.S. Food and Drug Administration approval for its R2 DigitalNow HD software, designed to process digitized film-screen mammograms for comparison.
June 16, 2009
FDA clears new Ziehm C-arm
By AuntMinnie.com staff writers
C-arm developer Ziehm Imaging has received clearance from the U.S. Food and Drug Administration for the company's latest mobile C-arm device.
June 10, 2009
FDA OKs NordicNeuroLab software
By AuntMinnie.com staff writers
NordicNeuroLab has received 510(k) clearance from the U.S. Food and Drug Administration to market its nordicICE Perfusion/Dynamic Contrast Enhanced (DCE) module.
June 10, 2009
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