RIVANNA, developers of world-first imaging-based medical technologies, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) regarding the Accuro

RIVANNA世界首创的基于成像的医疗技术的开发者，宣布其Accuro产品已获得美国食品药品监督管理局（FDA）的510(k)许可。

3S diagnostic ultrasound system and SpineNav-AI

3S诊断超声系统和SpineNav-AI

image processing software. This clearance authorizes the use of both technologies in

图像处理软件。此许可授权两种技术的使用在

United States

美国

hospital and clinical settings, providing anatomical guidance during needle or catheter placement.

医院和临床环境中，提供在放置针头或导管时的解剖学指导。

Accuro 3S

阿库罗 3S

is a portable, point-of-care ultrasound system with a proprietary, Dual-Array

是一款便携式、床旁超声系统，具有专有的双阵列技术

convex probe and integrated SpineNav-AI software. The Dual-Array probe consists of two aligned transducer arrays arranged side by side with a narrow gap, enabling an in-line needle approach through the probe's center. Images from both arrays are combined to optimize anatomical visualization. This platform supports standard B-mode imaging and is equipped with a touchscreen interface, a maneuverable cart-based form factor, and healthcare IT connectivity to implement DICOM-based patient and image archival workflows..

凸面探头和集成的SpineNav-AI软件。双阵列探头由两个并排排列的换能器阵列组成，中间有一个狭窄的间隙，允许通过探头中心进行在线针头穿刺。两个阵列的图像被合并以优化解剖结构可视化。该平台支持标准的B模式成像，并配备了触摸屏界面、可移动的推车式外形以及医疗IT连接功能，以实现基于DICOM的患者和图像存档工作流程。

SpineNav-AI

脊柱导航-AI

is a machine learning-based software solution that facilitates musculoskeletal imaging assessments of the lumbar spine to support real-time visualization during anesthesia procedures. It provides automated landmark detection and identification of critical spinal anatomy which may assist clinicians by standardizing interpretation of spinal images.

是一种基于机器学习的软件解决方案，有助于腰椎的肌肉骨骼成像评估，以支持麻醉过程中的实时可视化。它提供自动化的标志点检测和关键脊柱解剖结构的识别，可能通过标准化脊柱图像的解读来协助临床医生。

The software utilizes an AI-based image processing architecture to identify key anatomical structures in ultrasound images and indicate the position of the spine midline. The position of the epidural space and the measurement of depth to the epidural space are indicated when the epidural space is detected by the SpineNav-AI software..

该软件利用基于人工智能的图像处理架构来识别超声图像中的关键解剖结构，并指示脊柱中线的位置。当SpineNav-AI软件检测到硬膜外空间时，会显示硬膜外空间的位置以及到硬膜外空间的深度测量值。

'Achieving 510(k) clearance for Accuro 3S and SpineNav-AI ahead of schedule marks a significant milestone for RIVANNA and demonstrates the strength of our engineering and clinical partnerships. We are excited to introduce this next-generation platform to the market and continue advancing innovation in image-guided anesthesia procedures,' said .

“Accuro 3S 和 SpineNav-AI 提前获得 510(k) 许可，标志着 RIVANNA 的一个重要里程碑，也展示了我们工程和临床合作伙伴关系的实力。我们很高兴将这一下一代平台推向市场，并继续推进图像引导麻醉程序的创新。”

Will Mauldin

威尔·莫尔丁

, PhD, RIVANNA Co-founder and CEO.

，博士，RIVANNA联合创始人兼首席执行官。

The Accuro 3S platform builds on RIVANNA's clinically validated track record of increasing first-attempt success rates in spinal procedures. The system introduces enhanced imaging capabilities and integrated software tools to further support accuracy and efficiency in neuraxial anesthesia procedures.

Accuro 3S 平台基于 RIVANNA 在脊柱手术中提高首次尝试成功率的临床验证记录。该系统引入了增强的成像功能和集成的软件工具，以进一步提高神经轴麻醉手术的准确性和效率。

RIVANNA has implemented consumable products for the system, including a Probe Cover Needle Guide Kit, designed to stabilize probe positioning and facilitate needle alignment. This workflow enhancement will enable the clinician to locate the epidural space, assess its depth, and insert the needle under live visualization..

RIVANNA 已为系统实施了耗材产品，包括探头盖针导套件，旨在稳定探头位置并辅助针头对齐。这一工作流程的改进将使临床医生能够在实时可视化下定位硬膜外空间、评估其深度并插入针头。

This innovation tackles longstanding challenges in procedural guidance, according to Mauldin. 'Historically, ultrasound-guided neuraxial procedures have been limited by the need to simultaneously handle the needle, probe, and syringe, as well as by steep needle angles that restrict visualization, and difficulty maintaining a real-time in-plane approach with conventional probes.

据莫尔丁介绍，这一创新解决了程序指导方面的长期挑战。“历史上，超声引导的神经轴向操作一直受限于需要同时处理针头、探头和注射器，以及因针头角度过大而限制可视化，并且使用传统探头难以保持实时的平面内进针。”

Our solution addresses these technical barriers, making ultrasound guidance more accessible and supporting enhanced safety, precision, and patient care.'.

我们的解决方案解决了这些技术障碍，使超声引导更加普及，并支持提高安全性、精确性和患者护理。

RIVANNA's next steps include pursuing additional regulatory submissions for additional advanced Accuro 3S capabilities. Clinical collaborations are underway, with a forthcoming limited release of Accuro 3S to select leading academic medical centers, followed by a broader market launch.

里瓦娜的下一步包括为更多先进的Accuro 3S功能寻求额外的监管审批。临床合作正在进行中，计划向选定的领先学术医疗中心有限度地发布Accuro 3S，随后将进行更广泛的市场推广。

About RIVANNA

关于RIVANNA

RIVANNA is a commercial-stage medical device innovator and manufacturer based in

RIVANNA是一家处于商业化阶段的医疗器械创新者和制造商，总部位于

Charlottesville, VA

弗吉尼亚州夏洛茨维尔市

. The company develops and commercializes world-first imaging-based medical technologies that elevate global standards of care. RIVANNA offers early- and late-stage comprehensive imaging solutions for point-of-care spinal needle interventions and musculoskeletal diagnostics. Learn more:

该公司开发并商业化基于影像的全球首创医疗技术，提升全球护理标准。RIVANNA 提供针对脊柱针刺介入和肌肉骨骼诊断的早期和晚期全面影像解决方案。欲了解更多信息：