What's Happening?
Median Technologies has received FDA 510(k) clearance for its eyonis LCS, an AI-powered Software as a Medical Device (SaMD) designed for lung cancer screening. This clearance paves the way for the U.S. commercialization of the software. Oran Muduroglu has been appointed as President of Median eyonis Inc., the U.S. subsidiary of Median Technologies, to lead the launch and scale-up of eyonis LCS in the United States. The company has established a Medicare reimbursement pathway and is in discussions to form key clinical partnerships to enhance access to lung cancer screening programs across the U.S. The software aims to improve early diagnosis, reduce false positives, and enhance the clinical and economic performance of screening programs.
Why It's Important?
The FDA
clearance of eyonis LCS is significant as it introduces an advanced AI-powered tool to the U.S. healthcare market, potentially transforming lung cancer screening processes. By improving early diagnosis and reducing false positives, the software could lead to better patient outcomes and more efficient use of healthcare resources. The appointment of Oran Muduroglu, with his extensive experience in scaling imaging platforms, underscores the company's commitment to a successful U.S. launch. This development could also influence the adoption of AI technologies in other areas of medical diagnostics, setting a precedent for future innovations in healthcare.
What's Next?
Median Technologies plans to conduct webcasts on February 26, 2026, to discuss recent achievements and upcoming milestones for the deployment of eyonis LCS in the U.S. The company is also expanding its U.S.-based commercial and clinical support teams to support the launch strategy. Median is actively seeking additional non-exclusive distribution agreements with top-tier imaging and cloud technology partners to broaden the commercial adoption of eyonis LCS. The first U.S. sites are expected to be operational by the third quarter of 2026, with a focus on regions with strong lung cancer screening volumes and favorable reimbursement dynamics.
