Regulatory: Page 31

Pie software gets FDA nod
By AuntMinnieEurope.com staff writers
Imaging firm Pie Medical Imaging has received U.S. Food and Drug Administration clearance for its CAAS MR Flow software.
May 26, 2009
IMRIS wins CE Mark for MR angiography suite
By AuntMinnieEurope.com staff writers
Canadian intraoperative MRI technology developer IMRIS has received the CE Mark for its MR imaging and x-ray angiography suite.
April 30, 2009
Bracco revisits plans for U.S. launch of SonoVue
By AuntMinnieEurope.com staff writers
VIENNA - Italian contrast firm Bracco Imaging is reviving plans to launch its SonoVue contrast agent in the U.S. The Milan firm plans to sponsor a multicenter clinical trial this year to collect data for a regulatory submission to the U.S. Food and Drug Administration.
March 7, 2009
Varian wins CE Mark for proton therapy system
By AuntMinnieEurope.com staff writers
Radiation therapy firm Varian Medical Systems has received the European CE Mark for its proton therapy system.
February 19, 2009
Three Palm nets CE Mark
By AuntMinnieEurope.com staff writers
Breast imaging software developer Three Palm Software has received the CE Mark for its WorkstationOne and CadOne mammography software products.
January 19, 2009
iCAD debuts SecondLook with Planmed FFDM
By AuntMinnieEurope.com staff writers
Computer-aided detection (CAD) firm iCAD announced that its SecondLook digital CAD technology is now available outside the U.S. with Planmed's Nuance full-field digital mammography (FFDM) system.
December 30, 2008
Merit adds to product line
By AuntMinnieEurope.com staff writers
Disposable products developer Merit Medical Systems has added two new devices to its product line and received clearance from the U.S. Food and Drug Administration for its contrast management system.
December 29, 2008
IBA gets FDA nod for pencil-beam scanning
By AuntMinnieEurope.com staff writers
Radiopharmaceutical firm Ion Beam Applications (IBA) has received clearance from the U.S. Food and Drug Administration for its pencil-beam scanning treatment option for proton therapy.
December 18, 2008
IBA responds to FDA warning letter
By AuntMinnieEurope.com staff writers
Radiopharmaceutical firm Ion Beam Applications (IBA) has responded to a warning letter from the U.S. Food and Drug Administration related to manufacturing practices for PET radiotracers at a facility in Virginia.
December 10, 2008
Nucletron receives FDA clearance for RT viewer
By AuntMinnieEurope.com staff writers
Radiation oncology firm Nucletron has received clearance from the U.S. Food and Drug Administration for its radiotherapy (RT) viewer.
November 20, 2008
Medicsight submits 510(k) for ColonCAD
By AuntMinnieEurope.com staff writers
Computer-aided detection developer Medicsight has filed a 510(k) application to the U.S Food and Drug Administration for its ColonCAD image analysis software.
November 19, 2008
Riverain scores regulatory approvals
By AuntMinnieEurope.com staff writers
Computer-aided detection (CAD) developer Riverain Medical has received the European CE Mark and Canadian device licenses for its OnGuard chest x-ray CAD software and SoftView enhanced chest imaging technology.
November 18, 2008
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