Regulatory: Page 5

Thermal burns account for 60% of MRI adverse events
By Wayne Forrest
Ten years of MRI adverse event reports show burns from coils and electrocardiography leads during scans are among the most common -- and preventable -- causes for patient injuries, according to a large study presented on Thursday at the International Society for Magnetic Resonance in Medicine meeting.
August 13, 2020
2019 07 15 21 31 9496 Patient Safety 400
Guerbet brings Vectorio to Canadian market
By AuntMinnieEurope.com staff writers
Contrast developer Guerbet has received approval to market its Vectorio contrast media kit in Canada for imaging of hepatocellular carcinoma.
May 21, 2020
2019 12 18 19 15 2524 Guerbet Rsna 2019 400
EMA unveils new regulatory science strategy
By AuntMinnieEurope.com staff writers
The European Medicines Agency (EMA) has published a plan outlining its regulatory science strategy in both human and veterinary medicines for the next five years.
March 31, 2020
2019 03 18 21 52 0264 Eu Flag 400
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
2020 03 27 17 23 1132 Gavel European Union 400
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
2016 08 18 13 26 22 430 Breast Screening Mammo 400
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
2020 02 20 00 48 1332 Approved Stamp 400
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
2019 02 13 00 05 5620 Brexit Road Uk Eu Flags 400
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
2016 08 30 09 29 44 134 Radiation Symbol Circle 400
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
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