Thirona, a global leader specializing in advanced analysis of thoracic CT images using artificial intelligence, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for LungQ® 4, the latest version of its AI-powered CT analysis software.

This new clearance builds on version 3 of LungQ®, cleared by the FDA last year, which introduced advanced lung segmentation capabilities – a critical foundation for accurate analysis on a regional level.

LungQ® 4 extends these capabilities into:

• Enhanced peripheral airway segmentation.
• Estimated chronic perfusion defects from CT.
• Post-treatment detection of endobronchial implants.

The FDA clearance of LungQ® 4 underscores Thirona’s commitment to continuous innovation and performance leadership in AI-driven lung analysis. Since its inception in 2014, Thirona has remained focused on realizing its mission to translate validated AI technology into practical, clinically reliable tools designed to enhance pulmonary intervention planning and guidance, and to accelerate respiratory clinical trials evaluating treatment efficacy.

Enhanced Peripheral Airway Segmentation

Leveraging Thirona’s FDA-cleared and CE-certified segmentation framework, along with advanced deep learning models, LungQ® 4 provides enhanced airway segmentation analysis, enabling identification of distal airways within previously inaccessible peripheral regions of the lung. By combining this extended analysis with anatomical airway mapping, LungQ® 4 delivers detailed anatomical context that enhances clinical interpretation.

In navigational bronchoscopy, this can support precise access planning for distal airway targets in bronchoscopic interventions for the treatment of lung cancer, emphysema, and chronic airway diseases. In respiratory disease assessment, it can provide consistent anatomical referencing to visualize airway abnormalities up to the peripheral bronchial branches, enabling a clearer structural understanding of disease patterns within the bronchial tree.

Validated in a recently published study (1) comparing automated and manual assessments by expert bronchoscopist, this analysis demonstrated excellent accuracy and reliability, with a subcentimeter alignment between AI-identified pathways and expert-marked routes. This indicates that AI is ready to match, and potentially surpass, expert-level manual assessment for pre-procedural planning.

Functional Insight on Estimated Chronic Perfusion Defects from CT (PXT)

Already part of CE-certified LungQ® 3 and now FDA-cleared LungQ® 4, PXT applies deep learning to estimate approximate chronic perfusion defects directly from CT images, providing quantitative data for anatomical regions to support treatment target selection in lung volume reduction therapy and advancing quantitative imaging in functional lung assessment.

Earlier clinical evaluations confirmed that PXT delivers quantitative information comparable to SPECT-CT (2), which together with Thirona’s segmentation capabilities enables analyses of subsegmental regions.

Already available for clinical use in Europe, the UK, and Australia, this FDA clearance of PXT opens new opportunities for future integration of the analysis into precision-driven interventional workflows in U.S. hospitals.

Endobronchial Implants Detection – Toward an Integrated Treatment Pathway

The new analysis for detection of endobronchial implants in patients who have undergone lung volume reduction intervention, extends LungQ’s FDA-cleared capabilities to the post-treatment setting.

Offering automated detection and localization of endobronchial implants, the analysis provides information for post-treatment evaluation of implant positioning or displacement. This functionality complements LungQ’s established role in pre-procedural planning and patient eligibility assessment, paving the way toward integrated AI-supported treatment pathways, extending into follow-up and longitudinal monitoring.

Advancing Precision Pulmonary Care

“Each new FDA clearance is a great confirmation of our uncompromised focus on quality and performance, continuously improving our software to make a real impact in clinical practice,” said Eva van Rikxoort, PhD, CEO of Thirona. “With LungQ® 4, we’ve come a long way in translating our AI technology into trusted tools that actually work in everyday care, implemented in close collaboration with our partners across advanced clinical systems and solutions used by physicians around the world.”