Regulatory: Page 32

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
Covidien launches generic Cardiolite
By AuntMinnieEurope.com staff writers
Radiopharmaceutical firm Covidien has launched a generic version of Cardiolite, the technetium sestamibi radiopharmaceutical for SPECT myocardial perfusion imaging.
September 22, 2008
GE moves Optison agent through EU regulation
By AuntMinnieEurope.com staff writers
The European Medicines Agency (EMEA) has withdrawn the marketing authorization for GE Healthcare's Optison ultrasound contrast agent, a move that the company said is a routine part of the firm's effort to renew regulatory approval for the product.
July 22, 2008
aycan workstation OsiriX Pro gets CE Mark
By AuntMinnieEurope.com staff writers
aycan Digitalsysteme in Wuerzburg, Germany, has received the European CE Mark for its aycan workstation OsiriX Pro.
June 23, 2008
Elekta receives FDA nod
By AuntMinnieEurope.com staff writers
Swedish radiation oncology firm Elekta has received U.S. Food and Drug Administration 510(k) clearance for its Volumetric Intensity Modulated Arc Therapy technology.
June 16, 2008
PETNet gets U.K. FDG license
By AuntMinnieEurope.com staff writers
Siemens Healthcare said that its PETNet Solutions division has received a full Marketing Authorization and Manufacturer's/Importer's (MIA) license to produce and distribute its FDG biomarker from its Nottingham City Hospital site.
May 11, 2008
Dilon nets CE Mark
By AuntMinnieEurope.com staff writers
Scintimammography developer Dilon Technologies has received the European CE Mark for its Dilon 6800 gamma camera.
May 5, 2008
3mensio nets CE Mark for workstation
By AuntMinnieEurope.com staff writers
Advanced visualization developer 3mensio Medical Imaging of Bilthoven, Netherlands, has received the CE Mark Class IIa for its 3surgery vascular imaging workstation.
April 7, 2008
MediGuide Medical GPS gets CE Mark
By AuntMinnieEurope.com staff writers
MediGuide of Haifa, Israel, has received European CE Mark certification for its Medical Position System (MPS) and MPS-enabled Guided Measurement Catheter (GMC).
December 17, 2007
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