Tuesday, February 11, 2020

Very Brief Blog: FDA Pushes AI in Radiology; Will Hold Two Day Conference

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.