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FDA批准Arineta的深度学习图像重建技术

FDA Clears Arineta's Deep Learning Image Reconstruction Tech

mpo-mag 等信源发布 2024-02-16 18:46

可切换为仅中文


Arineta Cardio Imaging has won U.S. Food and Drug Administration (FDA) 510(k) clearance for its deep learning image reconstruction (DLIR) technology for use in the SpotLight family of cardiovascular CT (CCT) scanners. This next-generation image reconstruction technology, powered by artificial intelligence, allows Arineta to provide enhanced image quality and image noise reduction to its customers. .

Arineta Cardio Imaging凭借其用于SpotLight系列心血管CT(CCT)扫描仪的深度学习图像重建(DLIR)技术获得了美国食品和药物管理局(FDA)510(k)的许可。这种由人工智能支持的下一代图像重建技术使Arineta能够为其客户提供增强的图像质量和图像降噪。。。

DLIR utilizes an advanced deep learning convolutional neural network (CNN) that was trained on more than 3 billion image data points. In comparison to prior technology, DLIR decreases pixel-wise noise magnitude without reducing high-contrast spatial resolution.

DLIR利用先进的深度学习卷积神经网络(CNN),该网络在30多亿个图像数据点上进行了训练。与现有技术相比,DLIR在不降低高对比度空间分辨率的情况下降低了像素噪声幅度。

“Today, fewer than 5% of U.S. patients that need cardiac CT are getting appropriately scanned due to lack of access at point-of-care,” Arineta CEO Scott Schubert stated. “This FDA clearance continues Arineta’s vision and leadership to make cardiac CT the front-line imaging test for patients with chest pain and suspected cardiovascular disease, as recommended by the ACC & AHA 2021 guidelines.” .

Arineta首席执行官斯科特·舒伯特(ScottSchubert)表示:“今天,由于无法在护理点进行检查,需要心脏CT检查的美国患者中只有不到5%得到了适当的扫描。”。“根据ACC&AHA 2021指南的建议,FDA的批准延续了Arineta的愿景和领导力,使心脏CT成为胸痛和疑似心血管疾病患者的一线成像测试。”。。

DLIR is available on both of Arineta’s second-generation systems, including the SpotLight dedicated cardiovascular computed tomography (CT) and SpotLight Duo cardio-thoracic CT systems. SpotLight CT systems with DLIR are indicated for diagnosis of disease or abnormality and for planning of therapy procedures..

DLIR可用于Arineta的第二代系统,包括SpotLight专用心血管计算机断层扫描(CT)和SpotLight Duo心胸CT系统。带有DLIR的聚光灯CT系统适用于疾病或异常的诊断以及治疗程序的规划。。

“We have used Arineta cardiac CT systems for several years, and they provide the highest quality cardiac CT clinical images for our practice,” said Matthew Budoff M.D., professor, Endowed Chair of Preventive Cardiology at Harbor-UCLA. “From our FDA 510(k) reader study, Arineta’s DLIR technology continues that excellence.

“我们已经使用Arineta心脏CT系统好几年了,它们为我们的实践提供了最高质量的心脏CT临床图像,”加州大学洛杉矶分校海港分校预防心脏病学教授马修·巴多夫(MatthewBudoff)说。“从我们的FDA 510(k)读者研究中,Arineta的DLIR技术延续了这一卓越。

Arineta’s SpotLight systems make the highest performance cardiac CT available at point-of-care, in an office, mobile, or cath lab setting.”.

Arineta的SpotLight系统可在办公室、手机或cath实验室环境中提供最高性能的心脏CT。”。

Arineta Cardio Imaging is an Israeli company that develops and produces cardiovascular imaging solutions. Arineta is dedicated to growing cardiac CT as the front-line non-invasive test for diagnosing, therapy planning and monitoring of cardiovascular disease, the leading cause of death and costs for healthcare worldwide.

Arineta Cardio Imaging是一家开发和生产心血管成像解决方案的以色列公司。Arineta致力于将心脏CT作为诊断,治疗计划和监测心血管疾病的一线非侵入性测试,心血管疾病是全球医疗保健的主要死亡原因和成本。

Arineta’s flagship product, SpotLight Duo, is the world’s first dedicated single-heartbeat, whole-heart cardiovascular and thoracic CT, based on the company’s proprietary Stereo CT technology. Among Arineta’s scientists are the inventors of the multi-slice spiral CT technology, still the cornerstone of CT imaging.

Arineta的旗舰产品SpotLight Duo是世界上第一款基于公司专有立体CT技术的专用单心跳、全心心血管和胸部CT。Arineta的科学家中有多层螺旋CT技术的发明者,该技术仍然是CT成像的基石。

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