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Expert Review of Medical Devices Volume 20, 2023 - Issue 6
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Review

Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives

Alan G Frasera University Hospital of Wales, School of Medicine, Cardiff University, Heath Park, Cardiff, U.K;m KU Leuven, Leuven, BelgiumCorrespondence[email protected] [email protected]
ORCID Iconhttps://orcid.org/0000-0001-7083-6995View further author information
ORCID Icon,
Elisabetta Biasinb Centre for IT & IP Law (CiTiP), KU Leuven, Leuven, BelgiumView further author information
,
Bart Bijnensc Engineering Sciences, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, SpainView further author information
,
Nico Bruiningd Department of Clinical and Experimental Information processing (Digital Cardiology), Erasmus Medical Center, Thoraxcenter, Rotterdam, the NetherlandsView further author information
,
Enrico G Caianie Department of Electronics, Information and Biomedical Engineering, Politecnico di Milano, Milan, ItalyView further author information
,
Koen Cobbaertf Philips, Brussels, BelgiumORCID Iconhttps://orcid.org/0000-0001-5346-531XView further author information
ORCID Icon,
Rhodri H Daviesg Institute of Cardiovascular Science, University College London, London, U.KView further author information
,
Stephen H Gilberth Technische Universität Dresden, Else Kröner Fresenius Center for Digital Health, Dresden, GermanyView further author information
,
Leo Hovestadti Elekta, Stockholm, SwedenView further author information
,
Erik Kamenjasevicb Centre for IT & IP Law (CiTiP), KU Leuven, Leuven, BelgiumORCID Iconhttps://orcid.org/0000-0002-5160-7625View further author information
ORCID Icon,
Zuzanna Kwadej Dedalus HealthCare GmbH, Bonn, GermanyView further author information
,
Gearóid McGaurank Health Products Regulatory Authority, Dublin, IrelandView further author information
,
Gearóid O’Connork Health Products Regulatory Authority, Dublin, IrelandView further author information
,
Baptiste Vaseyl Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UKView further author information
&
Frank E Rademakersm KU Leuven, Leuven, BelgiumView further author information
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Pages 467-491 | Received 30 Oct 2022, Accepted 22 Feb 2023, Published online: 08 May 2023

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Maria Raffaella Martina, Chloe Park, Jordi Alastruey, Rosa Maria Bruno, Rachel Climie, Soner Dogan, Bilge Guvenc Tuna, Ana Jerončić, Marjan Manouchehri, Andrie G. Panayiotou, Silvia Tamarri, Dimitrios Terentes-Printzios, Marisa Testa, Areti Triantafyllou, Christopher C. Mayer & Elisabetta Bianchini. (2024) Medical device regulation in vascular ageing assessment: a VascAgeNet survey exploring knowledge and perception. Expert Review of Medical Devices 21:4, pages 335-347.
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Philippe Pinton. (2023) Impact of artificial intelligence on prognosis, shared decision-making, and precision medicine for patients with inflammatory bowel disease: a perspective and expert opinion. Annals of Medicine 55:2.
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Piotr Szymański, Frank Rademakers & Alan G Fraser. (2024) The Artificial Intelligence Act approved by the EU: the difficult dialogue between the black box and the cardiologist. European Heart Journal.
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Line Farah, Isabelle Borget, Nicolas Martelli & Alexandre Vallee. (2024) Suitability of the Current Health Technology Assessment of Innovative Artificial Intelligence-Based Medical Devices: Scoping Literature Review. Journal of Medical Internet Research 26, pages e51514.
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Flavio Giuseppe Biccirè, Dominik Mannhart, Ryota Kakizaki, Stephan Windecker, Lorenz Räber & George C. M. Siontis. (2024) Automatic assessment of atherosclerotic plaque features by intracoronary imaging: a scoping review. Frontiers in Cardiovascular Medicine 11.
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John R Campion, Donal B O'Connor & Conor Lahiff. (2024) Human-artificial intelligence interaction in gastrointestinal endoscopy. World Journal of Gastrointestinal Endoscopy 16:3, pages 126-135.
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Qingqing Wu, Xihong Li, Li Li, Ouyang Yan & Qingwen He. (2024) Analysis of factors affecting ultrasound examination time: A quantitative study. Technology and Health Care 32:2, pages 1015-1027.
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Alan G Fraser. (2023) A Counterblast to Pessimists and Naysayers – Intelligent Echocardiography Remains the Foundation Stone of Evidence-Based Clinical Cardiology. Romanian Journal of Cardiology 33:4, pages 138-140.
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Stephen Gilbert. 2023. Digital Respiratory Healthcare. Digital Respiratory Healthcare 63 78 .
Changye Chen, Ziyu Chen, Wenyu LuoYing Xu, Sixia Yang, Guozhao Yang, Xuhong Chen, Xiaoxia Chi, Ni Xie & Zhuoying Zeng. (2023) Ethical perspective on AI hazards to humans: A review. Medicine 102:48, pages e36163.
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Melissa D. McCradden, Shalmali Joshi, James A. Anderson & Alex John London. (2023) A normative framework for artificial intelligence as a sociotechnical system in healthcare. Patterns 4:11, pages 100864.
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