Median Technologies SA announced that the company has filed a 513(g) submission on Feb. 17, 2022 to the United States Food and Drug Administration (FDA) for its iBiopsy® Lung Cancer Screening (LCS) AI/ML technology-based end-to-end CADe/CADx1 Software as Medical Device (SaMD). The 513(g) submission will allow Median Technologies to determine the best product classification and choose between the De Novo or the 510(k) regulatory pathways for iBiopsy® LCS CADe/CADx SaMD.

The FDA is expected to review the 513(g) submission and provide feedback within 60 calendar days. As next regulatory steps, Median Technologies is preparing several Q-submissions for the second quarter of 2022.