Median Technologies receives FDA 510(k) clearance for eyonis® LCS

Median Technologies, based in Sophia Antipolis, announced that its lung cancer screening software, eyonis® LCS, has received 510(k) clearance from the FDA. This artificial intelligence-based medical device aims to provide early diagnosis, reducing false positives and limiting unnecessary tests. With a sensitivity of 93.3% and a negative predictive value of 99.9%, this software hopes to transform screening for some 14.5 million eligible individuals in the United States.

Despite the increase in screenings and the shortage of radiologists, eyonis® LCS integrates easily into existing systems, promoting more consistent and efficient follow-up. The company is planning a strategic expansion in the United States, combining direct sales and distribution partnerships.

Median continues its international expansion, aiming for CE certification in Europe soon. This technological advancement could significantly influence oncology diagnostics and save many lives.