Regulatory

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
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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
Liver
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
Computer Future Hologram
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
Endometriosis 3 D Illustration
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
2020 07 14 15 45 4340 Osteoporosis Hip Joint 400
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
2021 06 03 18 40 7810 Eu Flag 400
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
2020 02 24 17 44 7728 Clearance Stamp 400
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
2022 04 11 18 46 6299 Doctor Woman Ct Scan Lung2 400
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
2019 02 13 19 24 5396 Fda Logo V2 400
Brainomix secures FDA clearance for stroke AI software
By AuntMinnieEurope.com staff writers
Artificial intelligence (AI) software developer Brainomix has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its flagship e-ASPECTS stroke imaging software.
March 20, 2023
2020 02 24 17 44 7728 Clearance Stamp 400
Varian secures FDA clearance for Halcyon, Ethos radiotherapy systems
By AuntMinnieEurope.com staff writers
Varian, a Siemens Healthineers company, has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as the CE mark, for its Halcyon and Ethos radiotherapy systems featuring its HyperSight technology.
February 1, 2023
2020 07 15 17 09 6234 Quality Check Mark 400
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