Regulatory: Page 31

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
Medtronic gets CE Mark for MRI pacemaker
By AuntMinnieEurope.com staff writers
Interventional technology firm Medtronic has received the European CE Mark for a pacemaker designed for use in MRI systems.
November 16, 2008
Hologic nets CE Mark for Celero
By AuntMinnieEurope.com staff writers
Women's imaging vendor Hologic has received CE Mark approval for its Celero vacuum-assisted spring-loaded core biopsy device.
November 5, 2008
FDA OKs 3D mode for Biospace Med's EOS
By AuntMinnieEurope.com staff writers
French digital radiography developer Biospace Med has received 510(k) clearance from the U.S. Food and Drug Administration for a 3D skeletal reconstruction mode for its EOS digital x-ray system.
October 7, 2008
Sentinelle nets CE Mark
By AuntMinnieEurope.com staff writers
MRI technology developer Sentinelle Medical has received the European CE Mark for its Sentinelle Vanguard breast MR auxiliary table.
October 6, 2008
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