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BMJ Surgery, Interventions, & Health Technologies|November 3, 2025
Development of a minimum checklist to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performanceLotje A Hoogervorst, Rob G H H Nelissen, Tom Melvin, et al.
European Heart Journal|February 17, 2024
Device innovation in cardiovascular medicine: a report from the European Society of Cardiology Cardiovascular Round TableStephan Windecker, Martine Gilard, Stephan Achenbach, et al.
JACC. Cardiovascular Imaging|September 2, 2025
PRIME 2.0: An Update to The Proposed Requirements for Cardiovascular Imaging-Related Machine Learning Evaluation ChecklistNobuyuki Kagiyama, Márton Tokodi, Quincy A Hathaway, et al.
Acta Paediatrica (Oslo, Norway : 1992)|July 24, 2023
European expert recommendations on clinical investigation and evaluation of high-risk medical devices for childrenKathrin Guerlich, Bernadeta Patro-Golab, Alex Barnacle, et al.
The Lancet Regional Health. Europe|November 20, 2025
Recommended methodologies for clinical investigations of high-risk medical devices-Conclusions from the European Union CORE-MD ProjectAlan G Fraser, Sergio Buccheri, Robert A Byrne, et al.
Nature Medicine|April 4, 2025
Implementation of a national AI technology program on cardiovascular outcomes and the health systemTimothy A Fairbairn, Liam Mullen, Edward Nicol, et al.
European Heart Journal|February 20, 2025
Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round TableStephan Windecker, Alan G Fraser, Piotr Szymanski, et al.
European Heart Journal|August 9, 2014
New strategies for heart failure with preserved ejection fraction: the importance of targeted therapies for heart failure phenotypesMichele Senni, Walter J Paulus, Antonello Gavazzi, et al.
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