Median Technologies SA (4ZG.F), Monday announced that it has received FDA 510(k) clearance for eyonis LCS, an AI/ML-powered computer-aided detection and diagnosis Software as a Medical Device intended for lung cancer screening.
The clearance marks an important step for expanding access to AI-assisted lung cancer screening in the United States, the company noted.
The company also plans to commercialize eyonis LCS in the U.S. through a combination of direct enterprise sales, strategic distribution partnerships, and integration into existing clinical environments.
Simultaneously, Median is advancing its European regulatory pathway, with estimated CE marking in the second quarter of 2026.
Median's stock is currently trading at 4.4050 euros, up 5.26 percent on the Frankfurt Exchange.
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