French company Median Technologies has filed initial documents with the U.S. Food and Drug Administration (FDA) for regulatory review of its iBiopsy lung cancer screening software.
The 513(g) submission should provide the company with guidance from the FDA within 60 days on which regulatory pathway to use while seeking full clearance -- the 510(k) path or the de novo route.
IBiopsy was designed to detect lung nodules on low-dose chest CT.
