AI Diagnostics
AI software used to detect, classify, or flag disease findings from clinical data such as images or lab results.
AI diagnostics refers to software that uses machine learning to detect, classify, or flag potential disease findings from clinical data, most commonly medical images, but also lab values, pathology slides, or other structured data.
Most AI diagnostic tools are designed as an aid to the clinician who makes the final diagnosis, not a replacement for one. Whether a given tool requires FDA clearance depends on how it is marketed and used.