2023
DOI: 10.1016/j.artmed.2023.102607
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FDA-approved machine learning algorithms in neuroradiology: A systematic review of the current evidence for approval

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Cited by 6 publications
(5 citation statements)
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“…A recent systematic review of 53 algorithms with applications in the central nervous system revealed a concerning lack of substantial peer review, with only 10 algorithms being published, and a scarcity of rigorous clinical efficacy studies, often involving biased study populations. 13 These findings underscore the importance of advocating for and actively participating in the creation of regulatory frameworks for the use of AI/ML in neurology and NM medicine. This is particularly important in preventing unforeseen and unintentional harms which may arise from the premature deployment of healthcare AI applications which may have had suboptimal development (including inadequate AI model training) and pre-market testing.…”
Section: Working With Industry and Regulatory Aspects Of Ai In Edx An...mentioning
confidence: 97%
“…A recent systematic review of 53 algorithms with applications in the central nervous system revealed a concerning lack of substantial peer review, with only 10 algorithms being published, and a scarcity of rigorous clinical efficacy studies, often involving biased study populations. 13 These findings underscore the importance of advocating for and actively participating in the creation of regulatory frameworks for the use of AI/ML in neurology and NM medicine. This is particularly important in preventing unforeseen and unintentional harms which may arise from the premature deployment of healthcare AI applications which may have had suboptimal development (including inadequate AI model training) and pre-market testing.…”
Section: Working With Industry and Regulatory Aspects Of Ai In Edx An...mentioning
confidence: 97%
“…Another reason could be the high costs and resources associated with conducting rigorous clinical trials. The observed lack of a published research findings is not restricted to AI devices in mental healthcare but affects AI medical devices generally (Vokinger et al, 2021;Yearley et al, 2023).…”
Section: Clinical Evidencementioning
confidence: 99%
“…Regulatory oversight does not guarantee a product's external validity as the extent to which the results of a study can be generalized to and across other settings, individuals, and times (Andrade, 2018). Research has shown that AI tools have been approved with little or no efficacy data (Ebrahimian et al, 2022;van Leeuwen et al, 2021;Yearley et al, 2023). The absence of public information regarding the external validity of AI-CDSSs makes it difficult to justify their integration into clinical practice (Ebrahimian et al, 2022;Harada et al, 2021;Yearley et al, 2023).…”
mentioning
confidence: 99%
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“…In recent years, with the increasing availability of medical data and the continuous improvement in computer analysis capabilities, machine learning has been increasingly used in the medical field [ 23 , 24 ]. Machine learning is a technological application that uses algorithms and data to enable computers to automatically learn and enhance.…”
Section: Introductionmentioning
confidence: 99%