Regulatory

Opposition grows to EU wastewater treatment directive

By AuntMinnieEurope.com staff writers

Contrast media manufacturers and the medical imaging community will be watching closely for the outcome of a challenge to the EU Urban Wastewater Treatment Directive.

March 7, 2025

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Telix gets EU greenlight for Illuccix

By AuntMinnieEurope.com staff writers

Telix Pharmaceuticals announced a favorable decision from the European Union (EU) regarding marketing authorization for Illuccix in prostate cancer PET imaging.

January 17, 2025

RCR releases consultation update on 3 hot topics

By AuntMinnieEurope.com staff writers

The U.K. Royal College of Radiologists (RCR) has published details about how it has responded to three important healthcare issues currently out for consultation.

November 8, 2024

Guerbet achieves CE Mark for liver cancer AI software

By AuntMinnieEurope.com staff writers

DuOnco Liver integrated into Liflow 2.0 algorithms.

September 24, 2024

Icometrix gains EU approval for ARIA monitoring AI software

By AuntMinnieEurope.com staff writers

Icometrix has gained approval to market its icobrain aria software in the European Union (EU), along with Israel, Japan, Switzerland, and the U.K.

September 4, 2024

Brain Amyloid Plaque Neuron

AMRA Medical secures EU MDR certificate

By AuntMinnie.com staff writers

AMRA Medical has secured a Medical Device Regulation (MDR) certificate in Europe for its Profiler 4 MRI-based body composition analysis software.

August 30, 2024

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Serac's SPECT-CT agent gets regulatory approval

By AuntMinnieEurope.com staff writers

The Food and Drug Administration has granted fast-track designation to Serac Healthcare's maraciclatide technetium-99m as a diagnostic SPECT-CT agent to visualize and diagnose SPE.

July 2, 2024

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Medimaps receives certification for bone imaging software

By AuntMinnieEurope.com staff writers

Image processing AI software developer Medimaps Group has received Medical Device Regulation certification from its notified body BSI for its management system and product portfolio.

September 7, 2023

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Renew Europe group highlights AI Act adoption

By AuntMinnieEurope.com staff writers

The Renew Europe group is applauding the adoption of the Europe Union's Artificial Intelligence Act (AI Act) in the committees of civil liberties and of consumer protection.

May 10, 2023

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Advantis gets clearance for MRI analysis software

By AuntMinnieEurope.com staff writers

Dutch-based imaging software developer Advantis Medical Imaging has garnered U.S. Food and Drug Administration clearance for its Advantis Platform brain and prostate MRI analysis software.

April 16, 2023

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Annalise.ai receives approval for extra AI CT, x-ray indications

By AuntMinnieEurope.com staff writers

Australian-based artificial intelligence (AI) software developer Annalise.ai has secured clearances from the U.S. Food and Drug Administration (FDA) that cover additional indications for use of its CT and x-ray triage and notification software.

April 13, 2023

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New draft guidance becomes available for AI devices

By AuntMinnieEurope.com staff writers

The U.S. Food and Drug Administration has issued draft guidance and requested feedback on regulatory approaches for medical devices enabled by artificial intelligence (AI) and machine learning.

April 6, 2023

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