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5 May 2022, Sophia-Antipolis, France

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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21 April 2022, Sophia-Antipolis, France

Median Technologies reports full-year 2021 results and business indicators for the first quarter of 2022

Record high revenue of €5.7 million in Q1 2022, up 9.2% compared with Q1 2021 – Further growth in the order backlog to €62.3 million as of March 31, 2022, up 18.4% compared with March 31, 2021- Revenue of €20.5 million as of December 31, 2021, up 52.4% compared to December 31, 2020 – Cash and cash equivalents of €33.1 million as of March 31, 2022

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22 March 2022, Sophia-Antipolis, France

Median Technologies announces design completion of its iBiopsy® Lung Cancer Screening end-to-end CADe/CADx Software as Medical Device (SaMD) with outstanding sensitivity & specificity performance

iBiopsy® Lung Cancer Screening (LCS) CADe/CADx outstanding performance reaches 94.7% sensitivity[2] at 93.3% specificity, based on a cohort of 1,760 patients. With such performance, iBiopsy® LCS CADe/CADx SaMD positions itself to dramatically increase the efficacy of lung cancer screening programs worldwide, which would facilitate saving the lives of millions.

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3 March 2022, Sophia-Antipolis, France

Median Technologies files FDA 513(g) regulatory submission for iBiopsy® Lung Cancer Screening CADe/CADx Software as Medical Device

513(g) submission is a key milestone that marks the initiation of Median’s interactions with the FDA. 513(g) submission will allow Median Technologies to determine the best FDA regulatory pathway for iBiopsy® LCS CADe/CADx Software as Medical Device. Median aims to obtain a full device approval and market authorization by the end of 2023, and proceed with subsequent commercialization.

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