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


Thirona, a global company specializing in advanced analysis of thoracic CT images with artificial intelligence, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the latest update of its AI-based clinical software LungQ™ (v3.0.0), making its new features widely available for use in hospitals in the United States.

LungQ 3.0.0

LungQ 3.0.0 is one of the only FDA-cleared solutions that is capable of using AI to automatically segment the pulmonary segments and subsegments found in the internal anatomy of the lung. Based on this analysis, which includes the identification of structures such as lobes, segments, subsegments, airways, and fissures, the technology performs an analysis of the lung tissue and the fissure completeness, supporting physicians in the diagnosis and documentation of pulmonary tissue images from CT thoracic datasets for each individual patient.

“A clearer understanding of lung anatomy helps enable broader adoption of minimally invasive treatments for lung diseases such as COPD and lung cancer, helping save more healthy lung tissue and lung function capacity. Acting as a map for lung anatomy, LungQ helps guide bronchoscopic navigation, leveraging AI to significantly enhance the precision, accuracy, and efficiency of bronchoscopic and surgical lung interventions,” said Eva van Rikxoort, Founder and CEO of Thirona. “Solutions like LungQ are helping usher in a new era of personalized treatment for lung patients, enabling clinicians all over the world to conduct more advanced, easier-to-perform and less invasive procedures with full confidence.”

First Received 510(k) Clearance for Version 1.1.0 in 2018

The LungQ software first received 510(k) clearance for version 1.1.0 in 2018. With new enhancements, based on deep-learning technology, v.3.0.0 helps guide pulmonologists through the best approach to access various and most peripheral locations within the lungs by delineating pulmonary structures and providing highly accurate reproducible CT values for pulmonary tissue. These insights provide essential, non-invasive quantitative support for diagnosis, treatment planning and follow up examination of lung patients.

Rita Priori, CTO at Thirona Comments

“Our AI-based image analysis software LungQ is already used by interventional pulmonologists in Europe and Australia, aiding clinicians through procedures like bronchoscopic lung volume reduction and other interventions. We’re excited to build on the value we’re already seeing in the clinic, helping accelerate innovation in and adoption of a multitude of pulmonary interventions that require high precision on a subsegmental and segmental level, such as lung cancer biopsies, surgical lung volume reduction, lung segmentectomy, ablation procedures, and more.”

Approved for Clinical Use In Europe, the UK and Australia

The LungQ AI-powered software is approved for clinical use in Europe, the UK, and Australia. It is currently used by more than 600 hospitals and has been validated in more than 200 publications globally. The FDA 510(k) cleared LungQ opens tremendous new opportunities for planning and performing localized treatments with maximum precision and accuracy.

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Gabriel Sanchez, Ph.D., CEO and co-founder of Enspectra Health. "This significant achievement is the result of the excellent work by the Enspectra Health team and our clinical advisors. Our submission was cleared by the FDA ahead of plan, underscoring our ability to successfully drive an innovative technology from concept to clearance."

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