March 3, 2022 — Median Technologies 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/CADx 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 Q2, 2022.
“This first regulatory submission marks the beginning of our interactions with the FDA. The FDA’s feedback will help us determine the shortest and most efficient way to bring our product onto the US healthcare market”, Fredrik Brag, CEO and founder of Median Technologies said. “Lung cancer is the deadliest cancer, and being able to detect it very early is of critical importance for patients. Our innovative iBiopsy AI/ML-based technology could have a huge impact on saving patients’ lives by identifying lung cancer onsets at their earliest stage, and could significantly improve the accuracy, consistency, and adoption of lung cancer screening programs worldwide”.
For more information: www.mediantechnologies.com