Regulatory: Page 6

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

COCIR: Clock is ticking on MDR countdown

By AuntMinnieEurope.com staff writers

The European medical device community has one year to go until the Medical Device Regulation (MDR) goes into effect, but little progress has been made toward implementation of the regulatory scheme, according to the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR).

June 6, 2019

QUIBIM secures CE Mark for chest x-ray algorithm

By AuntMinnieEurope.com staff writers

Advanced image analysis software developer QUIBIM has received the CE Mark for its Chest X-Ray Classification software application.

May 27, 2019

EMA struggles with staffing issues after relocation

By AuntMinnieEurope.com staff writers

The European Medicines Agency (EMA) has acknowledged that it will require several more months to rebuild its workforce following its recent relocation from London to Amsterdam due to Brexit.

March 24, 2019

Spain probes anticompetitive PET practices

By AuntMinnieEurope.com staff writers

Spanish authorities have launched disciplinary proceedings against French molecular imaging firm Advanced Accelerator Applications and global nuclear medicine firm Curium for alleged anticompetition practices in Spain.

February 13, 2019

Oxipit gets CE Mark for ChestEye software

By AuntMinnieEurope.com staff writers

Artificial intelligence (AI) software developer Oxipit has received the CE Mark for ChestEye, its suite of analysis and reporting software for 75 common radiology findings.

February 5, 2019

GE gets EMA clearance for Rapiscan stressor in FFR

By AuntMinnieEurope.com staff writers

GE Healthcare announced that the European Medicines Agency (EMA) has approved its Rapiscan (regadenoson) pharmacological stress agent for on-label use in measuring fractional flow reserve (FFR) to identify hemodynamically or functionally significant stenosis.

January 28, 2019

QUIBIM awarded CE Mark for image analysis platform

By AuntMinnieEurope.com staff writers

Advanced image analysis firm QUIBIM has received CE Mark certification for its Precision image analysis platform.

January 13, 2019

Regulation needed to ensure safe use of AI in radiology

By Erik L. Ridley

Proper regulation is needed to ensure that artificial intelligence (AI) software is used safely, ethically, and appropriately with protection of patient privacy in radiology, according to Italian researchers in a review article recently published online in Insights into Imaging.

August 28, 2018

Previous Page

Page 6 of 34

Next Page