Publications by authors named "Alan Fraser"

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Implications of Structural Deterioration of the Trifecta Valve for the Evaluation and Regulatory Approval of High-Risk Medical Devices.
J J Coughlan, Rory Durand, Alan G Fraser, Robert A Byrne

Ann Thorac Surg· December 2025

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Inclusion and reporting by age, sex, and ethnicity in clinical studies of high-risk medical devices approved in the European Union.
J J Coughlan, Robert A Byrne, Georgios C M Siontis, Laurna McGovern, Rory Durand, Alan G Fraser

Eur Heart J Qual Care Clin Outcomes· November 2025

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Development of a minimum checklist to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance.
Lotje A Hoogervorst, Rob G H H Nelissen, Tom Melvin, Paul Piscoi, Chris Wilkinson, Alan G Fraser

BMJ Surg Interv Health Technol· November 2025

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Recommended methodologies for clinical investigations of high-risk medical devices-Conclusions from the European Union CORE-MD Project.
Alan G Fraser, Sergio Buccheri, Robert A Byrne, Per Kjaersgaard-Andersen, Stefan James

Lancet Reg Health Eur· November 2025

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PRIME 2.0: Proposed Requirements for Cardiovascular Imaging-Related Multimodal-AI Evaluation: An Updated Checklist.
Nobuyuki Kagiyama, Márton Tokodi, Quincy A Hathaway, Rima Arnaout, Rhodri Davies, Alan G Fraser

JACC Cardiovasc Imaging· August 2025

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Frequency of safety signals from scientific reports, manufactures, registers, and other sources for a random selection of hip and knee prostheses.
Yijun Ren, Lotje A Hoogervorst, Enrico G Caiani, Perla J Marang-van de Mheen, James A Smith, Alan G Fraser

Acta Orthop· June 2025

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Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table.
Stephan Windecker, Alan G Fraser, Piotr Szymanski, Martine Gilard, Thomas F Lüscher

Eur Heart J· April 2025

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Correction: Large simple randomized controlled trials-from drugs to medical devices: lessons from recent experience.
Sergio Buccheri, Stefan James, Marion Mafham, Martin Landray, Tom Melvin, Alan G Fraser

Trials· March 2025

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CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software.
Frank E Rademakers, Elisabetta Biasin, Nico Bruining, Enrico G Caiani, Rhodri H Davies, Alan G Fraser

NPJ Digit Med· February 2025

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Large simple randomized controlled trials-from drugs to medical devices: lessons from recent experience.
Sergio Buccheri, Stefan James, Marion Mafham, Martin Landray, Tom Melvin, Alan G Fraser

Trials· January 2025

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Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers.
Lotje A Hoogervorst, Yijun Ren, Tom Melvin, Ashley A Stratton-Powell, Anne Lübbeke, Alan G Fraser

Acta Orthop· November 2024

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Clinical evidence for high-risk CE-marked medical devices for glucose management: A systematic review and meta-analysis.
Arjola Bano, Juri Künzler, Faina Wehrli, Lum Kastrati, Tania Rivero, Alan G Fraser

Diabetes Obes Metab· October 2024

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Orphan and paediatric medical devices in Europe: recommendations to support their availability for on-label and off-label clinical indications.
Tom Melvin, Marc M Dooms, Berthold Koletzko, Mark A Turner, Damien Kenny, Alan G Fraser

Expert Rev Med Devices· October 2024

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Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee: Developed in collaboration with the European Heart Rhythm Association (EHRA), the Association of Cardiovascular Nursing & Allied Professions (ACNAP) of the ESC, the Heart Failure Association (HFA) of the ESC, the ESC Young Community, the ESC Working Group on e-Cardiology, the ESC Council for Cardiology Practice, the ESC Council of Cardio-Oncology, the ESC Council on Hypertension, the ESC Patient Forum, the ESC Digital Health Committee, and the European Association of Preventive Cardiology (EAPC).
Enrico G Caiani, Hareld Kemps, Petra Hoogendoorn, Riccardo Asteggiano, Allan Böhm, Alan G Fraser

Eur Heart J Digit Health· September 2024

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The Artificial Intelligence Act approved by the EU: the difficult dialogue between the black box and the cardiologist.
Piotr Szymański, Frank Rademakers, Alan G Fraser

Eur Heart J· August 2024

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A historical note on early clinical Doppler echocardiography in Norway.
Alan G Fraser, Bart Bijnens, George R Sutherland, Kjell Kristoffersen

Eur Heart J Cardiovasc Imaging· June 2024

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Device innovation in cardiovascular medicine: a report from the European Society of Cardiology Cardiovascular Round Table.
Stephan Windecker, Martine Gilard, Stephan Achenbach, Alain Cribier, Victoria Delgado, Alan G Fraser

Eur Heart J· April 2024

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Evidence from clinical trials on high-risk medical devices in children: a scoping review.
Kathrin Guerlich, Bernadeta Patro-Golab, Paulina Dworakowski, Alan G Fraser, Michael Kammermeier

Pediatr Res· February 2024

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Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium.
George C M Siontis, Bernadette Coles, Jonas D Häner, Laurna McGovern, Joanna Bartkowiak, Alan G Fraser

Eur Heart J· January 2024

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European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children.
Kathrin Guerlich, Bernadeta Patro-Golab, Alex Barnacle, Ulrich Baumann, Andreas Eicken, Alan G Fraser

Acta Paediatr· November 2023

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Clinical investigations to evaluate high-risk orthopaedic devices: a systematic review of the peer-reviewed medical literature.
Anne Lübbeke, Christophe Combescure, Christophe Barea, Amanda Inez Gonzalez, Keith Tucker, Alan G Fraser

EFORT Open Rev· November 2023

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Placing patient-reported outcomes at the centre of cardiovascular clinical practice: implications for quality of care and management.
Philip Moons, Tone M Norekvål, Elena Arbelo, Britt Borregaard, Barbara Casadei, Alan G Fraser

Eur Heart J· September 2023

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Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.
Lotje A Hoogervorst, Timon H Geurkink, Anne Lübbeke, Sergio Buccheri, Jan W Schoones, Alan G Fraser

Int J Health Policy Manag· August 2023

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Artificial intelligence in medical device software and high-risk medical devices - a review of definitions, expert recommendations and regulatory initiatives.
Alan G Fraser, Elisabetta Biasin, Bart Bijnens, Nico Bruining, Enrico G Caiani

Expert Rev Med Devices· June 2023

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Clinical evidence for high-risk medical devices used to manage diabetes: protocol for a systematic review and meta-analysis.
Arjola Bano, Markus Laimer, Faina Wehrli, Juri Kunzler, Tania Rivero, Alan G Fraser

BMJ Open· April 2023

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