Regulatory: Page 206

FDA clears Xoft treatment applicator
By AuntMinnie.com staff writers
Brachytherapy device developer Xoft has received clearance from the U.S. Food and Drug Administration for a skin and surface treatment applicator for use with its Axxent electronic brachytherapy system to deliver surface brachytherapy, including intraoperative radiation therapy.
March 4, 2009
FDA OKs Navistar catheter
By AuntMinnie.com staff writers
Image-guided interventional surgery firm Stereotaxis has received clearance from the U.S. Food and Drug Administration to market its Navistar RMT Thermocool catheter.
March 1, 2009
FDA clears Neuisys' NeuViz CT
By AuntMinnie.com staff writers
Neuisys has received 510(k) clearance from the U.S. Food and Drug Administration to market its NeuViz 16 multislice CT scanner.
February 23, 2009
Three Palm gets Canadian licenses
By AuntMinnie.com staff writers
Breast imaging software developer Three Palm Software has received Canadian Medical Device Licenses for its WorkstationOne breast imaging workstation software and CadOne mammography computer-aided detection (CAD) server.
February 23, 2009
Varian wins CE Mark for proton therapy system
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received the European CE Mark for its proton therapy system.
February 19, 2009
Acusphere amends Imagify NDA
By AuntMinnie.com staff writers
Ultrasound contrast developer Acusphere has submitted an amendment to its new drug application (NDA) for Imagify.
February 18, 2009
Bioptics gets nod for CoreVision
By AuntMinnie.com staff writers
Digital x-ray developer Bioptics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its CoreVision specimen radiography system.
February 9, 2009
Ultrasonix receives CE Mark for SonixTouch
By AuntMinnie.com staff writers
Ultrasound vendor Ultrasonix Medical has received the CE Mark for its SonixTouch ultrasound system.
February 5, 2009
Boston Scientific submits Taxus PMA data
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has submitted to the U.S. Food and Drug Administration the final modules of its premarket approval (PMA) applications for its Taxus Liberté Atom paclitaxel-eluting coronary stent system and its Taxus Liberté Long paclitaxel-eluting coronary stent system.
February 4, 2009
FDA clears SNM IND application
By AuntMinnie.com staff writers
Nuclear medicine organization SNM said that the U.S. Food and Drug Administration (FDA) has approved an SNM-sponsored, multicenter investigational new drug (IND) application for F-18-labeled 3'-deoxy-3'-fluorothymidine.
February 2, 2009
Boston Scientific to bring Taxus Liberté to Japan
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has received clearance from the Japanese Ministry of Health, Labour, and Welfare to market its Taxus Liberté paclitaxel-eluting coronary stent system.
January 28, 2009
Neusoft Positron files 510(k) for Attrius
By AuntMinnie.com staff writers
Positron joint venture Neusoft Positron Medical Systems in Shenyang, China, has submitted a 510(k) application to the U.S. Food and Drug Administration for its Attrius cardiac PET scanner product line.
January 28, 2009
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