Regulatory: Page 18

Making the invisible, visible: Meeting EU requirements on dose
By Dr. Jan Casselman, PhD
Implementing an effective dose management system will help hospitals meet the new European Union legislative requirements and enable radiologists to meet their ethical responsibility to maximize patient safety, writes Dr. Jan Casselman.
March 19, 2014
2014 03 19 13 32 43 430 Casselman Jan 200 20140319203309
Boston Scientific nets CE Mark for Ingevity
By AuntMinnieEurope.com staff writers
Boston Scientific has received the CE Mark for its Ingevity MRI-compatible pacing leads.
March 13, 2014
EOS gets CE Mark for hip arthroplasty planning software
By AuntMinnieEurope.com staff writers
EOS Imaging has received the CE Mark for hipEOS, a hip arthroplasty planning software based on its biplanar 3D imaging.
March 10, 2014
Planmed's Verity gets CE Mark for maxillofacial imaging
By AuntMinnieEurope.com staff writers
Planmed has received CE Mark approval for maxillofacial imaging with its Planmed Verity conebeam CT scanner.
March 9, 2014
Claron nets CE Mark for NilRead
By AuntMinnieEurope.com staff writers
Advanced visualization firm Claron Technology has received the CE Mark for its NilRead viewer.
March 6, 2014
AAA gets orphan drug status, buys private distributor
By AuntMinnieEurope.com staff writers
Advanced Accelerator Applications (AAA) has received orphan drug designation status for gallium-68 DOTATATE.
March 4, 2014
AAA gets orphan drug status
By AuntMinnieEurope.com staff writers
Advanced Accelerator Applications (AAA) has received orphan drug designation status for gallium-68 DOTATATE.
March 4, 2014
Piramal gets approval from EC for NeuraCeq
By AuntMinnieEurope.com staff writers
Radiopharmaceutical firm Piramal Imaging announced that its NeuraCeq radiotracer has received marketing authorization from the European Commission (EC).
February 25, 2014
TomTec gets FDA clearance for imaging software
By AuntMinnieEurope.com staff writers
TomTec Imaging Systems has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TomTec-Arena software.
December 2, 2013
Elekta gets FDA clearance for Monaco 5
By AuntMinnieEurope.com staff writers
Radiation oncology firm Elekta has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Monaco 5 radiation therapy treatment planning systems.
November 26, 2013
CMC lands Orphan Drug Designation by FDA
By AuntMinnieEurope.com staff writers
Swedish contrast media developer CMC Contrast has received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its CMC-001 liver-specific contrast agent.
November 26, 2013
IBA secures FDA clearance for imaging software suite
By AuntMinnieEurope.com staff writers
Radiopharmaceutical provider Ion Beam Applications has received U.S. Food and Drug Administration (FDA) clearance for its adaPT Insight imaging software suite.
November 26, 2013
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