A Food and Drug Administration advisory committee panel has voted unanimously to recommend approval for R2 Technology's ImageChecker CT computer-aided detection (CAD) system.
ImageChecker CT is designed to help radiologists detect and analyze lung nodules during review of multislice CT chest exams. The panel's recommendation does not bind the FDA to approve the device, R2 noted.
In January, the Sunnyvale, CA, firm received 510(k) clearance for temporal comparison tools on ImageChecker CT, which provides the capability to track nodule growth progression or regression over time.
The CT CAD system has been commercially available in Europe since March 2003, according to R2.
By AuntMinnie.com staff writersFebruary 4, 2004
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