Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis.

By Urs J. Muehlematter, P. Daniore, Kerstin N. Vokinger. The Lancet Digital Health, 2021

473 citations recorded by the source corpus.

There has been a surge of interest in artificial intelligence and machine learning (AI/ML)-based medical devices. However, it is poorly understood how and which AI/ML-based medical devices have been approved in the USA and Europe. We searched governmental and non-governmental databases to identify 222 devices approved in the USA and 240 devices in Europe. The number of approved AI/ML-based devices has increased substantially since 2015, with many being approved for use in radiology. However, few were qualified as high-risk devices. Of the 124 AI/ML-based devices commonly approved in the USA and Europe, 80 were first approved in Europe. One possible reason for approval in Europe before the USA might be the potentially relatively less rigorous evaluation of medical devices in Europe. The substantial number of approved devices highlight the need to ensure rigorous regulation of these devices. Currently, there is no specific regulatory pathway for AI/ML-based medical devices in the USA or Europe. We recommend more transparency on how devices are regulated and approved to enable and improve public trust, efficacy, safety, and quality of AI/ML-based medical devices. A comprehensive, publicly accessible database with device details for Conformité Européene (CE)-marked medical devices in Europe and US Food and Drug Administration approved devices is needed.

Subfields: Epidemiology, Health Informatics, Radiology, Nuclear Medicine and Imaging

View Paper: https://www.semanticscholar.org/paper/e2e3f4a17ce6b1f6bff4b38af82b722ad7620f79

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In Epidemiology

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In Radiology, Nuclear Medicine and Imaging

Citations in the corpus

Ethics and governance of trustworthy medical artificial intelligence (2023, background): “Food and Drug Administration (FDA) has approved a total of 222 AI medical device products, and Europe has approved a total of 240 AI medical device products with European conformity certification [97].”
The Role of AI in Hospitals and Clinics: Transforming Healthcare in the 21st Century (2024, background): “AI-based systems used in healthcare often require approval from regulatory bodies [175].”
From patterns to patients: Advances in clinical machine learning for cancer diagnosis, prognosis, and treatment. (2023, background): “EMA, most devices first received approval in Europe, suggesting a potentially lower regulatory bar compared to the US.(105)”
Artificial intelligence in healthcare: transforming the practice of medicine (2021, background): “34 38 We recognise that there are some exemplars in this area in the NHS (eg University of Leeds Virtual Pathology Project and the National Pathology Imaging Co-operative) and expect widescale adoption and scaleup of AI-based diagnostic imaging in the medium term.”
Towards accurate differential diagnosis with large language models (2023, background): “Deep learning tools have shown considerable promise in many areas of medicine, but are overwhelmingly used as assistive rather than autonomous tools [24], given the safety-critical nature of medical practice and the many issues of robustness [25] and fairness [26–28] seen in deployment.”