Infervision Receives FDA 510(k) Clearance for Advanced Features in InferRead CT Lung

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 represents a significant step forward in AI-enabled lung nodule detection and solidifies Infervision’s position as a global leader in providing high-precision imaging solutions for lung cancer screening and diagnosis within the U.S. healthcare system.

The latest approval introduces several critical advances in pulmonary nodule analysis. InferRead CT Lung now supports automated detection of nodules as small as 4 mm, enabling earlier detection 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 anatomic location. These additions allow for more complete and standardized nodule characterization, providing radiologists with consistent, quantifiable data to support accurate interpretation and confident clinical decision-making. Combined with Infervision’s proven sensitivity for detecting small nodules, this enhancement represents a significant advance in early lung cancer screening, and 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 can help physicians identify abnormalities such as emphysema, ILD, and other irregular density patterns. These chronic lung conditions, which are often not diagnosed until later stages, can now be detected earlier and more reliably. This capability provides clinicians with a broader perspective on lung health, supporting screening and management of at-risk groups such as smokers or those with long-term respiratory symptoms. One of the few AI lung cancer screening solutions currently offering automated lung density analysis, InferRead CT Lung offers unique value to both clinicians and patients, improving preventive care and enabling earlier intervention for life-threatening diseases.

Another important upgrade is the system’s ability to automatically compare current scans with previous studies, allowing changes in nodule size, shape and density to be tracked over time. This functionality supports longitudinal assessment, helps distinguish 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, providing healthcare organizations with a scalable and flexible deployment alternative. Built on a robust cybersecurity infrastructure, the solution ensures compliance with strict data protection standards and protects patient information in cloud environments. This deployment model enables organizations to adopt AI tools more easily and securely.

This FDA approval represents another major milestone in Infervision’s global regulatory footprint, which now includes approvals from the US FDA, European CE, UK UKCA, Japan PMDA, and China NMPA. Infervision remains committed to working with hospitals, physicians, and healthcare systems worldwide to bring intelligent, clinically validated AI solutions to everyday medical practice; empowering providers and improving outcomes for patients worldwide.