Jubilate Deus: RapidScreen CAD Receives Favorable Panel Review
This article was originally published in The Gray Sheet
Executive Summary
Labeling for Deus Technologies' RapidScreen computer-aided diagnosis (CAD) software for early detection of lung cancer should alert users that there may be substantial numbers of false negatives and positives associated with the device, FDA's Radiological Devices Panel stipulated March 5 in its review of the company's premarket approval application.
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