Regulatory: Page 8

Zebra secures CE Mark for additional AI algorithm
By AuntMinnieEurope.com staff writers
Big-data visualization software developer Zebra Medical Vision has secured the CE Mark for its newest algorithm running on the company's deep-learning imaging analytics platform.
March 4, 2018
iCAD gets CE Mark for PowerLook Tomo
By AuntMinnieEurope.com staff writers
iCAD has received the CE Mark for its PowerLook Tomo Detection 2.0 deep-learning computer-aided detection software for digital breast tomosynthesis.
March 1, 2018
EMA initiates approval process for Amsterdam HQ
By AuntMinnieEurope.com staff writers
The European Medicines Agency (EMA) has initiated a building approval process for its new headquarters in Amsterdam.
February 27, 2018
EMA: Amsterdam HQ won't be ready until November 2019
By AuntMinnieEurope.com staff writers
The management board of the European Medicines Agency (EMA) this week reaffirmed its decision to move from London to Amsterdam, but it revealed that its new permanent building won't be finished until 15 November 2019.
February 6, 2018
U.K., French regulators recall some gadolinium products
By AuntMinnieEurope.com staff writers
Regulators in both the U.K. and in France have issued recalls for certain gadolinium-based contrast agents for MRI, complying with an order issued last year from the European Medicines Agency.
February 6, 2018
EU chief says EMA's move to Amsterdam is a 'done deal'
By AuntMinnieEurope.com staff writers
The European Union (EU) is not reconsidering its decision to move the headquarters of the European Medicines Agency (EMA) to Amsterdam, according to comments made by Health Commissioner Dr. Vytenis Andriukaitis on Wednesday.
January 31, 2018
Italy may ask EMA to reconsider Dutch headquarters
By AuntMinnieEurope.com staff writers
Italians are making another bid to move the European Medicines Agency (EMA) headquarters to Milan.
January 29, 2018
EMA's move to Amsterdam hits a roadblock
By AuntMinnieEurope.com staff writers
The European Medicines Agency's (EMA) relocation to Amsterdam for its headquarters has hit a snag: The building won't be ready in time, according to Executive Director Guido Rasi.
January 28, 2018
Concern grows over medical radioisotopes post-Brexit
By AuntMinnieEurope.com staff writers
The European Scrutiny Committee said the U.K. government needs to explain how it will ensure a secure supply of medical radioisotopes after Brexit.
January 21, 2018
NHS releases guidance on cloud computing
By AuntMinnieEurope.com staff writers
The U.K.'s National Health Service (NHS) has published a guidance for health and social care organizations that plan to use public cloud services or data offshoring to cache patient data.
January 21, 2018
Combinostics gets FDA clearance for quantification software
By AuntMinnieEurope.com staff writers
Finnish software developer Combinostics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cNeuro cMRI quantification software.
January 15, 2018
Hologic receives CE Mark for breast biopsy system
By AuntMinnieEurope.com staff writers
Women's imaging firm Hologic received the CE Mark for its Brevera breast biopsy system with CorLumina workflow technology.
January 9, 2018
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