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Regulatory: Page 4
EC reschedules device regulations amid COVID-19 crisis
By
AuntMinnieEurope.com staff writers
The European Commission (EC) intends to postpone the Medical Device Regulation's date of application by a year amid the ongoing COVID-19 outbreak.
March 26, 2020
Breast screening suspended in Wales due to coronavirus
By
AuntMinnieEurope.com staff writers
The Welsh government has announced a plan to suspend nonurgent outpatient appointments and surgical procedures -- including breast cancer screening services -- in an effort to reduce the spread of COVID-19, according to an article from
County Times
posted on 20 March.
March 22, 2020
Behold.ai wins FDA approval for red dot AI algorithm
By
AuntMinnieEurope.com staff writers
U.K. artificial intelligence (AI) software developer Behold.ai has received U.S. Food and Drug Administration (FDA) clearance for its red dot AI triage algorithm.
March 11, 2020
U.K. officially withdraws from the EMA
By
AuntMinnieEurope.com staff writers
As of 1 February, delegates from the U.K. are no longer allowed to participate in meetings organized by the scientific communities, working parties, or management board of the European Medicines Agency (EMA).
February 2, 2020
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
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
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
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
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
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