Regulatory: Page 32

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The European Medicines Agency (EMEA) has withdrawn the marketing authorization for GE Healthcare's Optison ultrasound contrast agent, a move that the company said is a routine part of the firm's effort to renew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
BioSphere nets CE Mark OK
By AuntMinnieEurope.com staff writers
Interventional device developer BioSphere Medical has received the European CE Mark for transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) using its HepaSphere microspheres.
December 17, 2007
FDA OKs Compass dosimetry device
By AuntMinnieEurope.com staff writers
The U.S. Food and Drug Administration (FDA) has given 510(k) clearance to Stockholm-based RaySearch Laboratories and Ion Beam Applications (IBA) of Louvain-la-Neuve, Belgium, for their jointly developed Compass dosimetry device.
December 17, 2007
Vision RT nets FDA OK and several U.S. sales
By AuntMinnieEurope.com staff writers
U.K. radiation therapy developer Vision RT has received 510(k) clearance from the Food and Drug Administration (FDA) to market its GateCT and GateRT devices in the U.S.
October 28, 2007
European Commission delays MRI usage directive
By AuntMinnieEurope.com staff writers
The European Commission has postponed for at least five years the implementation of the EU Physical Agents Directive, which was designed to protect workers from the potentially harmful effects of electromagnetic fields, including those produced by MRI systems.
October 28, 2007
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