The US Food and Drug Administration (FDA) has recently cleared a groundbreaking lung cancer detection tool on Median Technologies’ eyonis platform, an artificial intelligence (AI)-based software suite designed for early cancer diagnosis.
This innovative tool, known as eyonis Lung Cancer Screening (LCS), is a Computer-Aided Detection and Diagnosis (CADe/CADx) Software as a Medical Device (SaMD) specifically created to analyze imaging data from CT scans. By assisting radiologists in identifying and characterizing parenchymal pulmonary nodules on the lungs, eyonis LCS aims to improve the accuracy and efficiency of lung cancer diagnosis.
The FDA clearance of eyonis LCS was supported by data from Median’s RELIVE pivotal trial, which demonstrated a statistically significant improvement when used in conjunction with a radiologist compared to a radiologist alone. With a sensitivity of 93.3%, specificity of 92.4%, and a Negative Predictive Value (NPV) of 99.9% in manufacturer performance testing, eyonis LCS has shown promising results in lung cancer screening.
Following the FDA approval announcement, Median Technologies’ stock saw a significant increase of 19% at market open, reaching €5.10 ($6.06) from a previous close of €4.28. By midday, the company’s stock had risen by around 50%, indicating a positive market response to the news. With a market cap of €156m, Median Technologies is poised for growth and expansion in the healthcare industry.
CEO and founder of Median Technologies, Fredrik Brag, expressed his belief that eyonis LCS will revolutionize clinical teams’ ability to manage increasing screening volumes and provide accurate and timely lung cancer diagnoses for eligible patients. The company plans to launch eyonis LCS in the US through a combination of direct enterprise sales, strategic distribution partnerships, and integration into existing clinical environments.
In addition to the FDA clearance, Median Technologies recently secured a €37.5m grant from the European Investment Bank (EIB) and €10m from an equity line with IRIS Capital Investment to support the FDA filing process. The company is also working towards obtaining a European CE mark for eyonis, expected to be achieved in the second quarter of 2026.
This milestone for Median Technologies comes amidst a growing trend of AI applications in healthcare, with the global AI in healthcare market projected to reach a valuation of $57.4bn by 2029. As medical imaging continues to benefit from technological advancements, tools like eyonis LCS are paving the way for more accurate and efficient cancer diagnosis and treatment.
