AI Takes Aim at Lung Cancer: FDA Clears First End-to-End Diagnostic Tool

SOPHIA ANTIPOLIS, France – February 09, 2026 – In a move that could significantly alter the landscape of cancer diagnostics, Median Technologies has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its eyonis® LCS software. The clearance marks a pivotal moment, establishing eyonis® LCS as the first AI-powered Software as a Medical Device (SaMD) cleared by the agency for both the detection and diagnosis of lung cancer in low-dose CT screenings.

The decision provides a powerful new weapon in the fight against lung cancer, which remains the leading cause of cancer-related death in the United States. By leveraging artificial intelligence and machine learning, the software is designed to help clinicians find and characterize potentially cancerous lung nodules earlier and more accurately, a critical factor in improving patient survival rates.

A New Standard in Early Detection

eyonis® LCS functions as a computer-aided detection and diagnosis (CADe/CADx) tool, analyzing images from Low-Dose CT (LDCT) scans to identify and assess parenchymal pulmonary nodules. Its distinction as an “end-to-end” solution is crucial; it is engineered not only to flag suspicious findings but also to provide diagnostic insights that help characterize them, streamlining the clinical workflow in a single step.

The performance data submitted to the FDA underscores its potential. In manufacturer testing, eyonis® LCS demonstrated 93.3% sensitivity in detecting cancer and 92.4% specificity, meaning it is highly effective at correctly identifying both the presence and absence of disease. Perhaps most impressively, the software achieved a 99.9% Negative Predictive Value (NPV). This near-perfect NPV provides clinicians a high degree of confidence that a negative result is truly negative, which can drastically reduce the number of false positives and prevent patients from undergoing unnecessary, costly, and often anxiety-inducing follow-up procedures.

“This FDA 510(k) clearance for eyonis® LCS is a major milestone for Median Technologies and an important step toward expanding access to AI-assisted lung cancer screening in the United States,” said Fredrik Brag, CEO and Founder of Median Technologies, in a statement. He added that the tool could be a “game changer for clinical teams as they manage rising screening volumes” and could “potentially help save hundreds of thousands of lives in the U.S. alone in the coming years.”

Addressing a Public Health Crisis

The timing of this clearance is critical. The American Cancer Society estimates that while early, localized lung cancer has a 5-year survival rate of around 80%, this figure plummets to approximately 15% once the disease has spread. The key to survival is catching the cancer at its most curable stage, which is the primary goal of LDCT screening programs.

Currently, an estimated 14.5 million Americans are eligible for lung cancer screening based on age and smoking history. However, managing this massive volume of scans presents a significant challenge for healthcare systems, which are already grappling with a nationwide shortage of radiologists. AI tools like eyonis® LCS are poised to alleviate this burden by improving diagnostic efficiency, reducing inter-reader variability, and ensuring a consistent standard of care across institutions.

Navigating a Competitive and Complex Market

Median Technologies enters a burgeoning market for AI in oncology diagnostics. The global market for AI in lung cancer diagnostics alone was valued at nearly $29 million in 2024 and is projected to soar to $114 million by 2030. North America is the dominant player, accounting for over half of the market share.

While Median touts eyonis® LCS as the first end-to-end device specifically for screening, it faces competition from other FDA-cleared AI tools. Qure.ai’s qCT LN Quant and RevealDX’s RevealAI-Lung also offer AI-powered nodule analysis. However, Median's emphasis on an integrated detection and diagnosis workflow for the specific purpose of lung cancer screening is its core differentiator.

A significant advantage for eyonis® LCS is its access to an established reimbursement pathway. The technology is covered under Category III CPT codes (0721T, 0722T), which allow for Medicare payments between $601 and $700 per use. This provides a clear financial incentive for adoption by U.S. imaging providers. However, the broader landscape for AI reimbursement remains challenging. One recent analysis of Medicare claims found a 53% denial rate for AI-related radiology services between 2018 and 2023, highlighting systemic hurdles that new technologies must overcome. The existence of specific CPT codes for eyonis® LCS is a crucial step in bypassing these general difficulties.

From Clinical Trials to Commercial Rollout

The FDA clearance was supported by robust clinical data from multiple pivotal studies, including the RELIVE and REALITY trials, which validated the software's analytical performance and its ability to improve radiologists' diagnostic accuracy in a clinical setting.

With clearance in hand, Median is executing a multi-pronged commercial strategy in the U.S. involving direct enterprise sales to healthcare systems, strategic distribution partnerships, and direct integration into hospital Picture Archiving and Communication Systems (PACS) to ensure seamless workflow adoption. The company had already signed its first non-exclusive distribution agreement with a leading U.S. healthcare company in December 2025, positioning it for a rapid launch.

Investment analysts are optimistic. Stifel has estimated the total addressable market in the U.S. at $10 billion and projects Median could see revenues of over €63 million from the device by 2030. The company’s ambitions extend beyond the U.S. and lung cancer, with plans to secure a CE mark for European sales by the second quarter of 2026 and to expand the eyonis® platform to tackle other cancers, including liver, pancreatic, and colon cancer.