Story thread · 2 reports / 2 sources

FDA Keeps Radiology AI Revenue Tied to Premarket Clearance

pymnts.com · 2hShare

The Food and Drug Administration is keeping a firm regulatory gate between a new radiology algorithm and its ability to generate revenue in the United States. An FDA final order that took effect Thursday (Sept. 17) requires several categories of artificial intelligence-enabled radiology software to continue receiving agency clearance before entering the market. The order formalizes the […] The post FDA Keeps Radiology AI Revenue Tied to Premarket Clearance appeared first on PYMNTS.com .

First report: FDA Awards Cognita Imaging $1.29M to Validate LLM-as-a-Jury Evaluation Across 1 Million Radiology Reports — hitconsultant.net, 1d