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The new directives demand higher levels of clinical evidence and high-risk devices will now have to demonstrate a clinically significant impact on the outcome for patients.” “The second ...

Date : 28/05/2018

The ESC welcomes this agreement and looks forward to engaging with regulatory authorities and HTA bodies in promoting excellence in patient management. The new rules will, for the first time, ...

Date : 26/05/2016

Standards of testing of medical devices are less rigorous in Europe than the US, where they have to undertake trials to show that the device has an impact on clinical outcomes, with the reality that ...

Date : 15/05/2011

In Europe, however, this situation should be considered as a stimulus for collaboration between experts in different imaging modalities, according to a paper entitled “The future of ...

Date : 04/07/2006

“With over 500,000 medical devices available in Europe, including many high-risk implantable devices that are used in our daily practice, cardiovascular medicine will be impacted ...

Date : 27/08/2018

In a position paper¹, the European Society of Cardiology (ESC) welcomes the European Commission’s (EC’s) proposals for a new Regulation to govern the evaluation and approval of ...

Date : 08/03/2013

[...]of his experiences, he believes that active collaboration between engineers and clinicians is crucial for the development of cardiovascular imaging. Cardiac ultrasound imaging is increasingly ...

Date : 07/12/2016