I just spent 20% of my time at RSNA arguing with people doing similar things and everyone seems to be happy to jump over the FDA’s existing bar for reconstruction algorithms. However previous reconstruction algorithms weren’t universal function approximators with the potential to exhibit abnormality-specific behavior.
We know very well these models have the capacity to recognize certain abnormalities or learn to model the normal state of anatomy. There is also the danger of the fact that deep learning powered reconstruction will not work alongside a radiologist like other AI for medical imaging applications such as nodule detection. This means we won’t find the problem with FDA’s low regulatory bar until patients start dying.
We know very well these models have the capacity to recognize certain abnormalities or learn to model the normal state of anatomy. There is also the danger of the fact that deep learning powered reconstruction will not work alongside a radiologist like other AI for medical imaging applications such as nodule detection. This means we won’t find the problem with FDA’s low regulatory bar until patients start dying.