Regulatory: Page 27

Heart valves and toasters: Call for new EU rules
By Reuters Health
PARIS (Reuters) - Pacemakers and electric toasters have little in common, yet in Europe the same regulatory framework covers both, and a growing number of doctors think the system is no longer up to the job. The issue has come to the fore at the European Society of Cardiology (ESC) congress.
August 29, 2011
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NeuroLogica gets CE Mark for inSPira HD
By AuntMinnieEurope.com staff writers
Portable scanner developer NeuroLogica has received CE Mark approval for its inSPira HD portable high-resolution SPECT camera.
August 15, 2011
French regulators remind rads on in-home imaging rules
By AuntMinnieEurope.com staff writers
The French Radiation Safety Authority, French Radiology Society, and French Association of Radiology Personnel have issued a joint statement on the requirements for physicians providing in-home radiology procedures -- with revised physician qualifications pending from the ASN.
July 18, 2011
Germany allocates funds for Mo-99 production
By AuntMinnieEurope.com staff writers
The German Federal Ministry of Health has awarded more than 1 million euros ($1.4 million U.S.) in R&D funding for producing the radioisotope molybdenum-99 (Mo-99) at the research neutron source Forschungs-Neutronenquelle Heinz Maier-Leibnitz (FRM II).
June 27, 2011
IBA, Wilex meet FDA on Redectane trial
By AuntMinnieEurope.com staff writers
Radiopharmaceutical developer Ion Beam Applications (IBA) and drug company Wilex recently met with the U.S. Food and Drug Administration to discuss the regulatory review process for IBA's Redectane PET/CT radiopharmaceutical.
June 19, 2011
COCIR lauds MRI exemption from EMF Directive
By AuntMinnieEurope.com staff writers
The European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR) has lauded the European Commission's new proposal for an Electromagnetic Field (EMF) Directive that excludes MRI technology from the exposure limit values.
June 14, 2011
Siemens gets CE Mark for PET/MRI scanner
By AuntMinnieEurope.com staff writers
Siemens Healthcare has received the CE Mark for its Biograph mMR hybrid PET/MRI scanner.
May 31, 2011
Olea gets Canadian regulatory nods
By AuntMinnieEurope.com staff writers
French software developer Olea Medical has received regulatory clearances in Canada for new versions of its PerfScape and NeuroScape software for diagnosing stroke and brain tumors.
May 11, 2011
IAEA creates database to record R/F incidents
By AuntMinnieEurope.com staff writers
The International Atomic Energy Agency (IAEA) has established an international database to report high radiation exposure incidents and adverse events relating to fluoroscopically guided diagnostic and interventional procedures.
May 5, 2011
InfraReDx gets CE Mark for IVUS system
By AuntMinnieEurope.com staff writers
Coronary imaging developer InfraReDx has received CE Mark approval to begin commercialization of its LipiScan intravascular ultrasound (IVUS) coronary imaging system throughout Europe.
April 20, 2011
Sectra nets Russian OK for digital mammo
By AuntMinnieEurope.com staff writers
PACS and digital mammography developer Sectra has received clearance to market its Sectra MicroDose Mammography system in Russia.
April 18, 2011
St. Jude to bring Accent MRI pacemaker to Europe
By AuntMinnieEurope.com staff writers
Cardiac technology developer St. Jude Medical has received the European CE Mark for its Accent MRI pacemaker and Tendril MRI lead.
April 17, 2011
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