Brainomix通过获得FDA里程碑式批准推进中风护理-动脉网

Brainomix Advances Stroke Care with Landmark FDA Clearance

CISION 等信源发布 2025-04-08 19:00

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Brainomix 360 unlocks expert-level insights from universally available non-contrast CT scans, helping stroke networks expand access to life-changing treatments

Brainomix 360从普遍可用的非对比CT扫描中解锁专家级见解，帮助中风网络扩大获得改变生命的治疗的机会。

OXFORD, England

牛津，英格兰

and

和

CHICAGO

芝加哥

，

April 8, 2025

2025年4月8日

/PRNewswire/ -- Brainomix, a global leader in AI-powered stroke imaging, has announced the FDA clearance of a novel and patented feature that enables physicians to assess ischemic core volume from universally available non-contrast CT (NCCT) images through the Brainomix 360 Stroke solution.

/PRENewswire/ -- Brainomix，一家全球领先的人工智能驱动的中风影像公司，宣布其获得FDA批准的一项新颖且获得专利的功能，该功能使医生能够通过Brainomix 360 Stroke解决方案从普遍可用的非对比CT（NCCT）图像中评估缺血核心体积。

The core volume feature has been studied and validated by leading US stroke centers, with results demonstrating equivalency to CT Perfusion and MRI-derived core volume assessments. This addresses a longstanding unmet need in stroke triage, enabling physicians across stroke networks to access expert-level insights to improve decision making for treatment and transfer of patients using routinely available brain scans..

核心体积特征已被美国领先的卒中中心研究和验证，结果表明其与CT灌注和MRI衍生的核心体积评估具有等效性。这解决了卒中分诊中长期未满足的需求，使卒中网络中的医生能够获取专家级的见解，从而利用常规可用的脑部扫描改进患者治疗和转运的决策。

'This key expansion of our Brainomix 360 platform marks a critical advancement in stroke imaging and reinforces our mission to transform stroke care through cutting-edge technology. Brainomix 360 empowers stroke teams by unlocking real-time, high-precision insights that can help expand patient access to life-changing treatments, including both thrombolysis and mechanical thrombectomy, for use up to 24 hours after stroke onset,' said .

“我们Brainomix 360平台的这次关键扩展标志着中风成像领域的一项重要进步，并进一步巩固了我们通过尖端技术改革中风护理的使命。Brainomix 360通过提供实时、高精度的洞察，助力中风团队扩大患者获得改变生命治疗的机会，包括溶栓和机械取栓，最长可用于中风发作后24小时内。”

博士

Michalis Papadakis

米哈利斯·帕帕达基斯

, CEO and Co-Founder at Brainomix.

，Brainomix 的首席执行官兼联合创始人。

Brainomix 360 is the only stroke AI imaging tool with a demonstrated impact on stroke treatment rates. Results from the largest real-world evaluation of stroke AI, incorporating national-level data from more than 450,000 patients over a 3-year period, found that Brainomix 360 was associated with a more than 50% increase in mechanical thrombectomy rates..

Brainomix 360 是唯一一种对中风治疗率产生显著影响的中风人工智能成像工具。针对中风人工智能的最大规模真实世界评估结果表明，在三年期间内，通过对超过 450,000 名患者的国家级数据分析发现，使用 Brainomix 360 与机械血栓切除术比率提升超过 50% 相关。

博士

Mehdi Bouslama

梅赫迪·布斯拉马

(Neuroendovascular Surgery & Vascular Neurology at Broward Health,

（布劳沃德健康中心的神经血管外科和血管神经科，

Florida

佛罗里达州

) co-authored a study published in

）共同撰写了一项发表在

Stroke

中风

with Dr

与博士

Raul Nogueira

劳尔·诺盖拉

and colleagues from

和来自的同事

Emory University

埃默里大学

validating Brainomix's NCCT core volume. 'The ability of Brainomix 360 to estimate ischemic core volumes in a reliable and reproducible manner with a similar performance to CT Perfusion represents an attractive alternative in centers without ready access to either advanced imaging modalities or stroke neurologist and/or neuroradiologist for imaging interpretation and has the potential to make endovascular therapy more widely available.'.

验证Brainomix的NCCT核心体积。 “Brainomix 360能够以与CT灌注相似的性能可靠且可重复地估计缺血核心体积，这在无法轻易获得高级成像技术或中风神经科医生和/或神经放射科医生进行影像解读的中心代表了一个有吸引力的替代方案，并有潜力使血管内治疗更为普及。”

博士

Kambiz Nael

康比兹·纳埃尔

(Professor of Neuroradiology at the

（神经放射学教授

University of California, San Francisco

加利福尼亚大学旧金山分校

) co-authored a study published in the

）共同撰写了一项发表在

Journal of Neurointerventional Surgery

神经介入手术杂志

(JNIS) that found Brainomix NCCT core volumes were comparable to those obtained from concurrent CT Perfusion. The study concluded: 'Our results demonstrate the ability of this algorithm to estimate ischemic core volumes from NCCT with similar performance to CTP and may be an attractive alternative in centers without ready access to advanced imaging modalities.'.

(JNIS) 发现 Brainomix NCCT 核心体积与同期 CT 灌注获得的结果相当。该研究总结道：“我们的结果证明了该算法能够从 NCCT 估算缺血核心体积，其性能与 CTP 相似，在无法方便获取高级成像技术的中心可能是一个有吸引力的替代方案。”

Dr Bouslama and Dr Nael will join an upcoming webinar, entitled

布萨拉姆博士和纳伊尔博士将参加一个即将举行的网络研讨会，主题为

'Imaging the Core on NCCT: Unlocking Stroke Insights Across Networks,'

“在NCCT上成像核心：解锁跨网络的中风见解，”

that will take place on

这将发生在

Thursday, April 24

4月24日，星期四

在

12pm EST

中午12点（东部标准时间）

. Click

. 点击

here

这里

to register for free.

免费注册。

About Brainomix

关于Brainomix

Brainomix specializes in the creation of AI-powered software solutions to enable precision medicine for better treatment decisions in stroke and lung fibrosis. With origins as a spinout from the University of

Brainomix 专注于开发人工智能驱动的软件解决方案，以实现精准医疗，从而为中风和肺纤维化提供更好的治疗决策。该公司起源于牛津大学的衍生公司。

Oxford

牛津

, Brainomix is an expanding commercial-stage company with offices in the UK,

，Brainomix是一家在英国设有办事处的、处于商业阶段的扩展型公司，

Ireland

爱尔兰

and the

和

USA

美国

, and operations in more than 20 countries. A private company, backed by leading healthtech investors, Brainomix has innovated award-winning imaging biomarkers and software solutions that have been clinically adopted in hundreds of hospitals worldwide. Its first product, the Brainomix 360 stroke platform, provides clinicians with the most comprehensive stroke imaging solution, driving increased treatment rates and improving functional independence for patients..

，并在20多个国家开展业务。作为一家私人公司，Brainomix得到了领先的健康科技投资者的支持，其创新的成像生物标志物和软件解决方案已在全球数百家医院得到临床应用。其首款产品Brainomix 360卒中平台为临床医生提供了最全面的卒中成像解决方案，提高了治疗率，并改善了患者的功能独立性。

To learn more about Brainomix and its technology visit

要了解有关Brainomix及其技术的更多信息，请访问

www.brainomix.com

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