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Thirona用于胸部CT图像人工智能分析的LungQ v3.0.0软件获得FDA 510(k)许可

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

businesswire 等信源发布 2024-01-22 20:15

可切换为仅中文


NIJMEGEN, Netherlands--(BUSINESS WIRE)--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..

荷兰奈梅亨——(商业新闻短讯)——Thirona是一家专门从事人工智能胸部CT图像高级分析的全球公司,它宣布已获得美国食品和药物管理局(FDA)510(k)的许可,以更新其基于AI的临床软件LungQ™ (v3.0.0),使其新功能在美国的医院中广泛使用。。

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..

LungQ 3.0.0是FDA批准的唯一能够使用AI自动分割肺部内部解剖结构中发现的肺段和亚段的解决方案之一。基于这种分析,包括识别肺叶、节段、亚节段、气道和裂隙等结构,该技术对肺组织和裂隙的完整性进行分析,支持医生诊断和记录每个患者的CT胸部数据集中的肺组织图像。。

“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.

“更清楚地了解肺部解剖结构有助于更广泛地采用微创治疗COPD和肺癌等肺部疾病,有助于保存更健康的肺组织和肺功能。作为肺部解剖的地图,LungQ有助于指导支气管镜导航,利用AI显着提高支气管镜和s的精确度,准确性和效率Thirona的创始人兼首席执行官Eva van Rikxoort说。

“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.”.

“像LungQ这样的解决方案正在帮助开创肺部患者个性化治疗的新时代,使世界各地的临床医生能够满怀信心地进行更先进,更容易执行和侵入性更小的手术。”。

Based on deep-learning technology, the LungQ software first received 510(k) clearance for version 1.1.0 in 2018. With new enhancements, 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 CT values for pulmonary tissue.

基于深度学习技术,LungQ软件于2018年首次获得1.1.0版510(k)许可。通过新的增强,v.3.0.0通过描绘肺部结构并为肺组织提供高度准确的CT值,帮助指导肺科医生通过最佳方法进入肺部的各种和最外围位置。

These insights provide essential, non-invasive quantitative support for diagnosis, treatment planning and follow up examination of lung patients..

这些见解为肺部患者的诊断,治疗计划和随访检查提供了必不可少的非侵入性定量支持。。

Rita Priori, CTO at Thirona: “Our AI-based image analysis software LungQ is already used by interventional pulmonologist 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.”.

丽塔先验,Thirona首席技术官:“我们基于人工智能的图像分析软件LungQ已经被欧洲和澳大利亚的介入性肺科医生使用,通过支气管镜肺减容和其他干预措施等程序帮助临床医生。我们很高兴能够在临床上已经看到的价值基础上再接再厉,帮助加速创新和采用需要的多种肺部干预措施在亚节段和节段水平上具有高精度,例如肺癌活检,外科肺减容,肺节段切除术,消融手术等。”。

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..

LungQ AI驱动的软件已被批准在欧洲,英国和澳大利亚临床使用。它目前被600多家医院使用,并已在全球200多份出版物中得到验证。FDA 510(k)批准的LungQ为以最大的精确度和准确性规划和执行局部治疗开辟了巨大的新机会。。

To learn more about the LungQ software, please visit our website.

要了解有关LungQ软件的更多信息,请访问我们的网站。

About Thirona

关于蒂罗纳

To help make personalized treatment in lung diseases accessible for everyone, Thirona leverages artificial intelligence to deliver high-precision advanced lung image analysis and expertise-based services for MedTech, pharmaceutical and CRO companies. Thirona also partners with research institutions and medical companies to enable breakthroughs in precision medicine for the personalized treatment of pulmonary diseases.

为了帮助每个人都能获得肺部疾病的个性化治疗,Thirona利用人工智能为MedTech、制药和CRO公司提供高精度的先进肺部图像分析和基于专业知识的服务。蒂罗纳还与研究机构和医疗公司合作,使精准医学在肺部疾病的个性化治疗方面取得突破。

Founded by female scientist and entrepreneur Eva van Rikxoort in 2014, the Company has established a proven track record of translating technology into certified clinical end-products through co-innovation with leading MedTech companies..

该公司于2014年由女性科学家和企业家伊娃·凡·里克索特(EvavanRikxoort)创立,通过与领先的医学技术公司的共同创新,该公司在将技术转化为经认证的临床最终产品方面取得了良好的业绩。。

Thirona’s state-of-the-art lung quantification platform LungQ™ consists of a comprehensive portfolio of robust high-performance AI-based algorithms trained on a wide range of disease-specific datasets, delivering consistent and reproducible results. The unique, scalable platform powers exploratory research studies as well as large multi-site clinical trials and has been cited in over 200 publications..

Thirona最先进的肺部量化平台LungQ™ 由在广泛的疾病特定数据集上训练的强大的基于AI的高性能算法的综合组合组成,可提供一致且可重复的结果。该独特的可扩展平台为探索性研究以及大型多站点临床试验提供了强大动力,已在200多篇出版物中被引用。。