Having just completed a rather good survey for IPEM on AI, its envisaged use, uptake and impact on my department, workflow etc.
I find that the FDA is providing a list of AI/ML-enabled medical devices marketed in the United States as a resource to the public about these devices and the FDA’s work in this area. The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the devices’ overall safety and effectiveness, which includes an evaluation of appropriate study diversity based on the device’s intended use and technological characteristics.
This list is not meant to be an exhaustive or comprehensive resource of medical devices that incorporate AI/ML. Rather, it is a list of medical devices that incorporate AI/ML across medical disciplines, primarily based on information provided in the summary descriptions of their marketing authorization document.
Do any such device lists exist in the UK?
I suppose the MHRA is a good place to start.