Tool allowing radiologists to interact with AI imaging data receives FDA first-of-kind determination

A system that compiles artificial intelligence-generated imaging data into one place for radiologist analysis has been determined ready for commercialization by the FDA, according to Foster City, Calif.-based TeraRecon, a developer of digital radiology solutions.

The Northstar AI Results Explorer can be incorporated directly into existing clinical workflows. Within the platform, radiologists can not only view AI-produced images and reports, but also assess individual measurements, markings and other findings generated by the technology, examining the AI's decision-making process to determine and fine-tune the data's accuracy and thus accept or reject the algorithm's findings.

The FDA gave the platform a "first-of-kind" determination, labeling it a Class I medical device and therefore granting it full commercial availability.

Editor's note: This article was updated June 25 at 9:00 a.m. to clarify the FDA's determination.

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