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Escardio

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
Escardio

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
Escardio

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
Escardio

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
Escardio

“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
Escardio

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
Escardio

[...]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
Escardio

“Yet so much remains to be done,” she continued. “We have a duty to be unrelenting in our calls for greater investment in CVD and a renewed focus on drug development, innovation and ...

Date : 01/09/2019
Escardio

Prof. Fraser and the ESC Regulatory Affairs Committee, part of ESC Advocacy, have been heavily involved as stakeholders in influencing the new regulation, which has an expanded scope compared with ...

Date : 01/09/2019
Escardio

Based on these values and the need for a serious governance framework, we embarked on a revision of the ESC Statutes and continued the work of ESC Past-President, Jeroen Bax, on refining processes ...

Date : 04/09/2019