Pathology, Radiology, and AI
We think of radiology and pathology as the two diagnostic specialities. We talk about AI in both (on the pathology side, see e.g. Sloan Kettering's spinout PAIGE-AI which raised $45M this winter. Not to be out-done, New York's nearby Mt Sinai also has a lab AI spinout, Renalytics_AI.)
On the radiology side, literally, hardly a single issue of Journal of American College of Radiology (JACR) gets published without an article on AI-related policy and science issues for its industry and its physician membership.
FDA Produces De Novo Ultrasound/AI Clearance; Issues White Papers; Will Hold Public Meeting Feb 25-26, 2020
FDA has produced a De Novo clearance of a novel ultrasound-AI device for cardiology. See MedCityNews here, see Healthcare Dive here. The product comes from Caption Health here, and the FDA press release is here. The FDA 5-page DN approval is here; DN190040.
The FDA has a whole new regulatory category for these devices, AI in Imaging - Product code QJU, category 891.2100, here, and FDA produced a major white paper on the topic last year.
FDA Conference: AI in Imaging, February 25-26, 2020
See the FDA's web page, with extensive agenda, for a February 25-26, 2020, conference on AI in imaging - here.
Separate from AI in radiology, see an article about non-radiologists interpreting advanced imaging; here.