French imaging software developer Median Technologies has secured nearly $50 million to support regulatory filings for its AI lung cancer diagnostic software as a medical device (SaMD).
Several financial decisions have extended the company’s cash runway for this year, including a European Investment Bank (EIB) loan for 37.5 million euros ($39.4 million) and a 10 million euro ($10.5 million) equity line from IRIS Capital Investment, according to Median.
The money will be used to seek regulatory approval from the U.S. Food and Drug Administration (FDA) and CE mark for the eyonis lung cancer screening (LCS) SaMD, as well as for ongoing active commercialization partnership discussions with U.S. providers of AI diagnostics, Median said.
Eyonis LCS is an AI-powered diagnostic device that uses machine learning to help analyze imaging data generated with low-dose computed tomography to diagnose lung cancer, according to Median. The company noted that it expects to gather key study data for the device in the first quarter of 2025, FDA regulatory approval, and CE marking in Q2, and that it plans to launch the device in the U.S. in Q4.