Median Technologies Submits FDA 510(k) Application for AI-Powered Lung Cancer Screening Software
核心洞察
Median Technologies (搜索) has filed for FDA 510(k) clearance of eyonis® LCS (搜索), an AI-powered software for early lung cancer (搜索) detection, with approval expected in Q3 2025 based on standard review timelines.
The application is supported by two successful pivotal studies, REALITY (搜索) and RELIVE (搜索), which demonstrated the software's ability to accurately detect lung nodules with an AUC of 0.904 and significantly improve radiologists' diagnostic performance.
The U.S. market opportunity includes 14.5 million eligible screening candidates, representing a potential $10 billion annual market, with eyonis® LCS (搜索) positioned to improve early detection rates and patient outcomes.
Median Technologies (搜索) has submitted an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of eyonis® LCS (搜索), its artificial intelligence-powered software designed for early lung cancer (搜索) detection and diagnosis. The company anticipates receiving clearance in the third quarter of 2025, based on average review timelines for radiological medical devices.
The submission follows positive results from two pivotal clinical studies, both of which met their primary endpoints. These studies demonstrated the software's robust diagnostic capabilities in detecting and characterizing lung nodules in high-risk populations.
Strong Clinical Evidence Supports Application
The REALITY (搜索) study, completed in August 2024, showed that eyonis® LCS (搜索) can accurately detect and characterize lung nodules with exceptional performance, achieving an area under the curve (AUC) value of 0.904, significantly exceeding the minimum threshold of 0.80 set as the primary endpoint.
The RELIVE (搜索) study, completed in March 2025, demonstrated that radiologists using eyonis® LCS (搜索) achieved statistically significant improved performance compared to radiologists working without the software (p=0.027). This improvement in diagnostic accuracy could potentially transform the efficiency of low-dose computed tomography (LDCT) scan analysis in lung cancer (搜索) screening programs.
"eyonis® LCS (搜索)' FDA filing is a major milestone for Median and a testament to our R&D and clinical programs' strength," said Fredrik Brag, CEO and Founder of Median Technologies (搜索). "RELIVE (搜索) and REALITY (搜索) pivotal studies met their primary endpoints and confirmed the device's safety and efficacy. This shows that eyonis® LCS has the potential to be a game-changer in lung cancer (搜索) screening."
Addressing a Critical Public Health Need
Lung cancer (搜索) screening is currently recommended by the U.S. Preventive Services Task Force (USPSTF) for adults aged 50 to 80 years with a 20 pack-year smoking history. This recommendation creates a substantial market opportunity, with approximately 14.5 million eligible individuals in the U.S. alone.
With existing reimbursement potential of $650 per exam for software that can characterize malignant versus benign nodules, the total addressable annual market exceeds $10 billion. This market is expected to grow as eligibility criteria broaden and as new lung screening programs deploy across Europe and Asia.
The timing is critical, as the direct medical costs of cancer patient care in the U.S. were estimated at nearly $230 billion in 2023. The majority of these costs are associated with treating advanced cancer, highlighting the economic and clinical value of early detection technologies like eyonis® LCS (搜索).
How eyonis® LCS Works
eyonis® LCS (搜索) is a Software as a Medical Device (SaMD) that employs machine learning algorithms to analyze imaging data from low-dose computed tomography scans. The software is designed to aid radiologists in diagnosing lung cancer (搜索) at its earliest stages, when treatment is most effective and can potentially save lives.
The technology serves as both a computer-aided detection (CADe) and computer-aided diagnosis (CADx) tool, helping clinicians identify suspicious nodules and characterize them as potentially malignant or benign. This dual functionality addresses two critical challenges in lung cancer (搜索) screening: detection of subtle abnormalities and accurate characterization to reduce false positives.
Potential Impact on Clinical Practice
If cleared, eyonis® LCS (搜索) could significantly impact clinical practice by increasing the efficiency and accuracy of lung cancer (搜索) screening programs. The software may enable healthcare professionals to process more screening exams with greater confidence in their diagnostic accuracy.
"By providing early detection and characterization at scale, eyonis® LCS (搜索) can significantly improve high-risk patient outcomes," Brag noted. This improvement could translate to earlier interventions, better survival rates, and potentially reduced healthcare costs associated with treating advanced lung cancer (搜索).
About Median Technologies
Median Technologies (搜索) is a French company that specializes in innovative software as medical devices and imaging services. The company leverages artificial intelligence to enhance early cancer diagnosis and treatment monitoring.
In addition to eyonis® LCS (搜索), Median offers iCRO, a service that provides medical image analysis and management for oncology clinical trials. The company maintains a presence in the United States and China, and is traded on the Euronext Growth market.
As lung cancer (搜索) screening programs continue to expand globally, technologies like eyonis® LCS (搜索) may play an increasingly important role in improving detection rates and patient outcomes in high-risk populations.