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they are not meant to replace human expertise. Instead, AI acts as a supportive tool, providing insights
and facilitating the diagnostic procedure. As the technology continues to advance, we can expect AI to
further improve and expand its applications, supporting the transformation of traditional medical
practices.
Clinicians will need to adapt to their new roles as information integrators, interpreters and patient
supporters, and the medical education system will have to provide them with the tools and methods to do
so. Who will end up controlling, certifying or profiting from the application of AI is still to be
determined, and therefore the balance of regulatory safeguards and market forces to ensure that patients
benefit most must be a high priority.
According to a report published by the FDA, the adoption of AI/ML-enabled devices exhibited a
noteworthy trajectory in recent years. After a remarkable 39% surge in 2020 compared to 2019, the year-
over-year growth slowed to 15% in 2021 and 14% in 2022. However, projections for 2023 suggest a
resurgence with an anticipated increase surpassing 30%. Radiology emerges as the frontrunner in this
technological shift, accounting for 87% of devices authorized in 2022 and maintaining a dominant
position with 79% of devices through July 2023. Notably, the radiology sector has consistently
demonstrated the most substantial increase in AI/ML-enabled device submissions across various medical
specialties.[5]
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sophisticated and integrative machine learning solutions, emphasizing both innovation and practical
effectiveness.
39%
30%
15% 14%
[1] K. H. Yu, A. L. Beam, and I. S. Kohane, “Artificial intelligence in healthcare,” Nature Biomedical
Engineering, vol. 2, no. 10. Nature Publishing Group, pp. 719–731, Oct. 01, 2018. doi: 10.1038/s41551-
018-0305-z.
[2] L. Vicente and H. Matute, “Humans inherit artificial intelligence biases,” Sci Rep, vol. 13, no. 1, p.
15737, Oct. 2023, doi: 10.1038/s41598-023-42384-8.
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