Infervision is proud to announce that its flagship product, InferRead® Lung CT.AI, has received FDA 510(k) clearance for multiple newly enhanced features. This milestone marks a significant step forward in AI-driven lung nodule detection and strengthens Infervision’s position as a global leader in delivering high-precision imaging solutions for lung cancer screening and diagnosis within the U.S. healthcare system.

The latest clearance introduces several critical advancements in pulmonary nodule analysis. InferRead CT Lung now supports the automated detection of nodules as small as 4 mm, enabling earlier identification of potentially malignant lesions. The updated system also introduces expanded, structured assessments of key clinical parameters—including long and short nodule diameters, nodule density and anatomical localization These additions enable more complete and standardized nodule characterization, equipping radiologists with consistent, quantifiable data to support accurate interpretation and confident clinical decision-making. Combined with Infervision’s proven precision in detecting small nodules, this enhancement represents a meaningful advancement in early lung cancer screening, where timely diagnosis significantly improves patient outcomes, particularly among high-risk populations.

In parallel with its nodule analysis capabilities, the system now features an FDA-cleared lung density analysis function. This tool could assist physicians in identifying abnormalities such as emphysema, ILD and other irregular density patterns. Often underdiagnosed until later stages, these chronic pulmonary conditions can now be identified earlier and more reliably. This feature provides clinicians with a broader view of lung health, supporting the screening and management of at-risk groups such as smokers or individuals with long-term respiratory symptoms. As one of the few AI lung cancer screening solutions currently offering automated lung density analysis, InferRead CT Lung delivers unique value to both clinicians and patients, enhancing preventive care and enabling earlier intervention for life-threatening diseases.

Another significant upgrade is the system’s ability to automatically compare current scans with prior studies, allowing for the tracking of changes in nodule size, shape, and density over time. This functionality supports longitudinal evaluation, assists in differentiating benign from malignant lesions, and helps reduce unnecessary follow-up or invasive procedures.

To meet the evolving demands of modern imaging environments, InferRead CT Lung now supports cloud-based deployment, offering healthcare institutions a scalable and flexible implementation alternative. Built on a robust cybersecurity infrastructure, the solution ensures compliance with strict data protection standards and safeguards patient information across cloud environments. This deployment model enables institutions to adopt AI tools with greater ease and confidence.

This FDA clearance represents another important milestone in Infervision’s global regulatory footprint, which now includes approvals from the U.S. FDA, European CE, UK UKCA, Japan PMDA, and China NMPA. Infervision remains committed to working alongside hospitals, physicians, and healthcare systems worldwide to bring intelligent, clinically validated AI solutions into everyday medical practice—empowering providers and improving outcomes for patients across the globe.