Regulatory: Page 6

SERAM releases document on medical radiation regulations
By AuntMinnieEurope.com staff writers
The Spanish Society of Medical Radiology (SERAM) has published a document explaining about the implementation of European Union (EU) regulations covering medical radiation.
January 26, 2020
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European court affirms EMA's policy on study data
By AuntMinnieEurope.com staff writers
The European Court of Justice has affirmed a policy maintained by the European Medicines Agency (EMA) on the transparency of data from clinical studies and toxicology reports.
January 22, 2020
U.S. DOE waives export ban on highly enriched uranium
By AuntMinnieEurope.com staff writers
The U.S. Department of Energy (DOE) is moving to allow the export of weapons-grade uranium, the same substance used to manufacture medical isotopes, such as molybdenum-99.
January 8, 2020
2020 01 09 20 52 3661 Molybdenum Element 400
French radiologists call for payments for CBCT of the ear
By AuntMinnieEurope.com staff writers
Conebeam CT (CBCT) is superior to CT for visualizing the ear in cases of conductive hearing loss, and hopefully it will soon be reimbursed by the national health system, delegates heard on Thursday in Paris ahead of the French national radiology meeting, Journées Francophones de Radiologie.
October 10, 2019
Exact Imaging receives CE Mark for new needle guide
By AuntMinnieEurope.com staff writers
Ultrasound technology developer Exact Imaging has received the CE Mark for use of its sterile transperineal needle guide with the company's EV29L transducer.
September 10, 2019
Interval breast cancer screening comes under scrutiny in Ireland
By AuntMinnieEurope.com staff writers
The Irish government's agency for health and social care services, the Health Service Executive, is investigating the review of breast cancer screening mammography exams performed outside of the standardized audit process, according to a 12 August article on RTE.ie.
August 12, 2019
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COCIR responds to EC's draft standardization document
By AuntMinnieEurope.com staff writers
The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) has filed a response to a draft publication by the European Commission (EC) that seeks to harmonize medical regulations in Europe.
July 24, 2019
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Mindshare secures CE Mark for lung cancer AI
By AuntMinnieEurope.com staff writers
Artificial intelligence (AI) software developer Mindshare Medical has received the CE Mark for the sale of its RevealAI-Lung, AI-based software designed to detect lung cancer on CT scans.
July 14, 2019
COCIR: Clock is ticking on MDR countdown
By AuntMinnieEurope.com staff writers
The European medical device community has one year to go until the Medical Device Regulation (MDR) goes into effect, but little progress has been made toward implementation of the regulatory scheme, according to the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR).
June 6, 2019
QUIBIM secures CE Mark for chest x-ray algorithm
By AuntMinnieEurope.com staff writers
Advanced image analysis software developer QUIBIM has received the CE Mark for its Chest X-Ray Classification software application.
May 27, 2019
EMA struggles with staffing issues after relocation
By AuntMinnieEurope.com staff writers
The European Medicines Agency (EMA) has acknowledged that it will require several more months to rebuild its workforce following its recent relocation from London to Amsterdam due to Brexit.
March 24, 2019
Spain probes anticompetitive PET practices
By AuntMinnieEurope.com staff writers
Spanish authorities have launched disciplinary proceedings against French molecular imaging firm Advanced Accelerator Applications and global nuclear medicine firm Curium for alleged anticompetition practices in Spain.
February 13, 2019
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