Median Technologies is moving forward with the FDA interactions for its iBiopsy® Lung Cancer Screening CADe/CADx Software as Medical Device
Median has received the FDA’s feedback following the 513(g) regulatory submission for its iBiopsy® LCS CADe/CADx Software as Medical Device. Median will proceed through a 510(k) submission to obtain an FDA device clearance and market authorization, targeted for end 2023. On May 2, 2022, Median initiated a Q-submission process, composed of several submissions, to request feedback from the FDA on various topics such as the pivotal study protocols.
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