FDA Grants 510(k) Clearance to Thirona's LungQ v3.0.0 Software for AI Analysis of Chest CT Images

Monday, January 22, 2024

Thirona, a global leader specializing in advanced analysis of thoracic CT images through artificial intelligence, recently announced the FDA 510(k) clearance for the latest iteration of its AI-based clinical software, LungQ™ (v3.0.0). This regulatory approval allows the updated features to be implemented in U.S. hospitals. LungQ 3.0.0 is distinguished as one of the few FDA-cleared solutions adept at utilizing AI for the automatic segmentation of pulmonary segments and subsegments within the internal anatomy of the lungs. The software identifies structures like lobes, segments, subsegments, airways, and fissures, enabling an analysis of lung tissue and fissure completeness. This functionality supports physicians in diagnosing and documenting pulmonary tissue images derived from CT thoracic datasets for individual patients.

A clearer comprehension of lung anatomy encourages wider adoption of minimally invasive treatments for lung diseases like COPD and lung cancer, preserving healthy lung tissue and function. Serving as a map of lung anatomy, LungQ assists in bronchoscopic navigation, employing AI to enhance precision, accuracy, and efficiency in bronchoscopic and surgical lung interventions. Solutions such as LungQ contribute to a new era of personalized treatment for lung patients, empowering clinicians globally to conduct more advanced, easily-performed, and less invasive procedures with confidence.

LungQ, built on deep-learning technology, initially received FDA 510(k) clearance for version 1.1.0 in 2018. The latest version, v3.0.0, guides pulmonologists in accessing various peripheral lung locations by delineating pulmonary structures and providing highly accurate CT values for pulmonary tissue. These insights offer crucial, non-invasive quantitative support for diagnosis, treatment planning, and follow-up examinations for lung patients.

Although LungQ's AI-powered software is approved for clinical use in Europe, the UK, and Australia, the recent FDA 510(k) clearance opens up significant opportunities for planning and executing localized treatments with maximum precision and accuracy. Currently employed by over 600 hospitals, LungQ has been validated in more than 200 publications globally.


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