Researchers urge FDA to improve the credibility of AI devices by ensuring clinical validation and appropriate transparency in the approval process.
A recent study revealed The fact that almost half of the AI medical devices approved by the United States Food and Drug Administration (FDA) have not been trained on the real patients of patients. Out of 521 devices examined, 43% lacked published clinical validation, which raises concerns concerning their effectiveness in real contexts.
The study stresses that only 22 of these devices were validated by randomized controlled trials, considered as “the ordeal” for clinical tests. Some devices were based on “ghost images” instead of real patient data, while others used retrospective or prospective validation methods. Researchers emphasize the importance of appropriate clinical validation to ensure that these technologies are safe and effective.
The researchers hope that their results will encourage the FDA and the medical industry to improve the credibility of AI devices by conducting and publishing clinical validation studies. They believe that improving transparency and rigor of these processes will have a significant impact on patient care.
In Australia, similar regulations exist, therapeutic Products Administration (TGA) requiring AI software to provide information on its training data and its ability to the Australian population. Medical devices must also comply with general clinical evidence directives to ensure safety and efficiency.