Upcoming CORE-MD Webinar on Pivotal Clinical Investigations of High-Risk Medical Devices: “What Guidance Do We Need and by Whom?”
Register today for the upcoming CORE-MD Webinar on “Pivotal Clinical Investigations of High-Risk Medical Devices: “What Guidance Do We Need and by Whom?“ taking place on Monday 27 November 2023 from 17:00 to 18:15 CET. Moderator: Prof. Alan Fraser The Webinar will address the following topics: Learning Objectives:
CORE-MD Webinar on the high-risk medical devices in the field of cardiovascular disease and diabetes available for REPLAY
The CORE-MD consortium organised its sixth webinar on high-risk medical devices in the field of cardiovascular disease and diabetes moderated by Prof. Robert Byrne, Director of Cardiology and Director of the Cardiovascular Research Institute at Mater Private Network, Dublin, Ireland. Learning Objectives: Visit our webinar web page to see the upcoming webinars and to download the presentations of […]
A systematic review of the peer-reviewed medical literature
The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force in May 2021 of the EU Medical Device Regulation. Authors: Anne Lübbeke, Christophe Combescure, Christophe Barea, Amanda Inez Gonzalez, Keith Tucker, Per Kjærsgaard-Andersen, Tom Melvin, […]
Upcoming CORE-MD Webinar on high-risk medical devices in the field of Cardiovascular Disease and Diabetes
Register today for the upcoming CORE-MD Webinar on “What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes? Results and implications of the CORE-MD systematic reviews“ taking place on Monday 06 November 2023 from 17:00 to 18:15 CET. Moderator: Prof. Robert Byrne. The Webinar will address the following topics: Learning Objectives:
CORE-MD Webinar on AI available for REPLAY
On Tuesday 17 of October 2023, the CORE-MD consortium organised its fifth webinar on The clinical evaluation of Artificial Intelligence and standalone software. The REPLAY is now available. Moderated by Em. Prof. Frank Rademakers, the learning objectives of the webinar were: Visit our webinar web page to see the upcoming webinars and to download the presentations of the panelists.
Upcoming CORE-MD Webinar on clinical evaluation of Artificial Intelligence
Register today for the upcoming CORE-MD Webinar on “The clinical evaluation of Artificial Intelligence and standalone software: keeping the balance between benefit and risk.“ taking place on Monday 17 October 2023 from 17:00 to 18:30 CET. Moderator: Claudia Wild, AIHTA/ CORE-MD The Webinar will address the following topics: Learning Objectives: Please help us to share knowledge within the scientific community and forward […]
Evidence from clinical trials on high-risk medical devices in children: a scoping review
Pediatric Research published a new systematic review on clinical trials elaborated by Kathrin Guerlich, Bernadeta Patro-Golab, Paulina Dworakowski, Alan G. Fraser, Michael Kammermeier, Tom Melvin & Berthold Koletzko. Meeting increased regulatory requirements for clinical evaluation of medical devices marketed in Europe in accordance with the Medical Device Regulation (EU 2017/745) is challenging, particularly for high-risk devices used in children. Within the CORE-MD […]
CORE-MD work on Paediatric devices presented at the International Medical Device Regulators Forum
The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonisation and convergence. IMDRF produces guidance documents aiming […]
Lack of published evidence for high-risk medical devices in Europe – new findings from CORE-MD
Investigators from the CORE-MD Project revealed at the end of August in the European Heart Journal that a majority of new high-risk medical devices that are used to treat heart disease have been released to the market in the European Union (EU) with insufficient evidence from clinical trials. That means that too little information about […]
CORE-MD partners presented their results at the ESC Congress
The ESC Congress took place in Amsterdam from 25th to 28th August 2023. Several CORE-MD partners presented their results during the various sessions of this major Scientific Congress. 𝗣𝗿𝗼𝗳 𝗔𝗹𝗮𝗻 𝗙𝗿𝗮𝘀𝗲𝗿, chairperson of the ESC TV 📺 Special Session “Clinical evidence for high-risk devices“, engaged in an insightful discussion with Stephen Windecker and Perla Marang-van de Mheen who shared […]