条例
RIVANNA 赢得FDA 关于Acuro XV的BoneEnhance AI模块的许可
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RIVANNA 宣布 2026年10月22日，美国食品药品管理局批准了BoneEnhance的510(k)许可，BoneEnhance是该公司Acuro XV诊断超声系统的一个机器学习软件模块。 模块将骨骼和周围组织分解，并在图像审查期间支持骨骼解剖在三个维度的可视化。
以弗吉尼亚州为基地的夏洛茨维尔公司开发了AI辅助临床决策支持系统，将BoneEnhance描述为为Accuro XV平台清理的第一个机器学习软件模块。 RIVANNA将批准设定为将平台从获取转向解释：Accuro XV进行体积图像获取，BoneEnhance标注其中的解剖学。 基础系统于2026年4月被清除，根据释放结果，用于肌骨常规和表面应用中的B型模具成像；RIVANNA公开宣布，即2026年5月7日早些时候的清除。
BoneEnhance如何在Accuro XV上工作
每次自动Acuro XV收购都产生一个量子数据集供审查。 在该体积内，BoneEnhance识别骨骼和周围组织，然后在二维B-mode图像上用彩色编码的覆盖标记它们。 上面部分使原始解剖数据保持不变，在下面可见，屏幕上有一个三维指示器显示扫描方向和显示的切片坐落在收购体积之内。
共同创始人兼CEO威尔·毛尔丁·称·里凡纳(英语：Will Mauldin 称 RIVANNA)是为解决削减跨护理环境的问题而设立的：决策关键信息位于护理点工作流程之外。 Mauldin 称称清关是目前正在开发的决策支持能力的基础。
以推车为主的Accuro XV采用具有机动化线性翻译的可调性三维探测器，通过10厘米扫描范围获取B-mode图像，在初步患者定位后实现大视野获取自动化。 符合要求的聚氨酯对峙介质形成患者接触面，符合不规则的解剖，以改善声学耦合。 该系统包括一个触摸屏接口，一个用于点点移动的综合电池包，以及DICOM兼容的图像存档工作流程。
2026年5月7日，该系统的宣布批准合格及训练有素的医护专业人士在医院及医疗诊所环境中，RIVANNA 称综合工作流程得到全球知识产权组合的支持，该组合涉及20多个专利家族的100多份已发和待发专利。
通过八个站点验证
BoneEnhance在RIVANNA的全国八点临床研究中得到了培训和验证。 三个站点提供了培训数据，另外五个站点提供了一套233个体积数据集的独立测试，其中包括来自173个学科的69 900幅图像。 根据该发布，测试数据都没有用于培训或调试。 三位经委员会认证的放射学家建立了参考标签，RIVANNA报告说，每卷标签的预测精度，即解剖标签的度量，介于95.1%至100.0%之间。
该公司除了支持BoneEnhance许可的验证之外，还引用了平台自动购置的同行评审证据。 在"急诊医学杂志"上发表的对205名患者的研究中，拥有一小时手动训练的操作人员收购手腕和脚踝图像在超过90%的扫描中被评为足以诊断解释的图像，其图像质量与医生-收购扫描相当。 RIVANNA先前的审批公告称，该研究是在UVA Health和UT西南医疗中心进行的，并将非医生操作员与经董事会认证的急诊医生进行比较。
研究成长和伤害检测模块
BoneEnhance背后的临床研究继续增长。 2026年4月，RIVANNA 宣布称研究从两个站点扩大到八个站点——丹佛健康，德克萨斯技术健康埃尔帕索，加利福尼亚大学，旧金山，犹他大学，UVA健康，UT西南医疗中心，弗吉尼亚联邦大学，耶鲁大学——在生物医学高级研究与开发管理局(BARDA)执行资助方案后。 在那个阶段，程序是训练CADE/x,RIVANNA称这是第一个计算机辅助检测算法，用于从体积超声波成像中自动识别断裂，并完成了BoneEnhance的验证。
根据新版，该研究后来从8个站点扩大到10个站点，并正在建设用于培训Acuro XV调查性肌肉骨骼损伤检测模块的数据集。 在BoneEnhance给解剖学贴上标签的地方，正在开发调查模块，以协助临床医生评估收购超声波图像中潜在的极限断裂。 发布中指出，由于网站和数据基础设施已经建立过一次，而且每个新模块都被重新使用，因此随后的每个模块都建立在方案的联邦投资上。
RIVANNA的市场准入和战略伙伴关系高级主管Delphine Le Roux赞扬了参与的临床场所和BARDA持续支持清关后的证据方案。 “我们为BoneEnhance建立的基础设施、伙伴关系和管理游戏手册旨在继续发展，”
根据75A50121C00035号合同，该项目全部或部分得到了美国卫生与公众服务部、战略准备和反应管理局以及BARDA的联邦资金的支持。
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Regulation
RIVANNA Wins FDA Clearance for BoneEnhance AI Module on Accuro XV
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RIVANNA announced on October 22, 2026, that the U.S. Food and Drug Administration granted 510(k) clearance for BoneEnhance, a machine learning software module for the company’s Accuro XV diagnostic ultrasound system. The module segments bone and surrounding tissues and supports visualization of skeletal anatomy in three dimensions during image review.
The Charlottesville, Virginia-based company, which develops AI-enabled clinical decision-support systems, described BoneEnhance as the first machine learning software module cleared for the Accuro XV platform. RIVANNA framed the clearance as moving the platform from acquisition toward interpretation: the Accuro XV performs the volumetric image acquisition, and BoneEnhance labels the anatomy captured within it. The underlying system was cleared in April 2026 for B-mode imaging in musculoskeletal conventional and superficial applications, according to the release; RIVANNA publicly announced that earlier clearance on May 7, 2026.
How BoneEnhance Works on the Accuro XV
Each automated Accuro XV acquisition produces a volumetric dataset for review. Within that volume, BoneEnhance identifies bone and surrounding tissues, then marks them with color-coded overlays on the two-dimensional B-mode image. The overlays leave the original anatomical data unchanged and visible underneath, and an on-screen three-dimensional indicator shows the scan’s orientation and where the displayed slice sits within the acquired volume.
Co-founder and CEO Will Mauldin said RIVANNA was founded to address a problem that cuts across care settings: decision-critical information sitting outside the point-of-care workflow. “BoneEnhance is where the stack begins to close that gap for musculoskeletal care: automated volumetric acquisition, now paired with cleared software-assisted review,” Mauldin said, calling the clearance the foundation for decision-support capabilities now in development.
The cart-based Accuro XV uses a conformable three-dimensional probe with motorized linear translation to acquire B-mode images across a 10-centimeter scan extent, automating large field-of-view acquisition after initial patient positioning. A compliant polyurethane stand-off medium forms a patient contact surface that conforms to irregular anatomies to improve acoustic coupling. The system includes a touchscreen interface, an integrated battery pack for point-of-care mobility, and DICOM-compatible image archival workflows.
The system’s earlier clearance, announced on May 7, 2026, authorized commercial use of the Accuro XV for musculoskeletal imaging by qualified and trained healthcare professionals in hospital and medical clinic environments. RIVANNA says the integrated workflow is backed by a worldwide intellectual-property portfolio of more than 100 issued and pending patents across more than 20 patent families.
Validation Across Eight Sites
BoneEnhance was trained and validated within RIVANNA’s nationwide eight-site clinical study. Three sites contributed the training data, and the other five provided an independent test set of 233 volumetric datasets comprising 69,900 images from 173 subjects. According to the release, none of the test data were used for training or tuning. Three board-certified radiologists established the reference labels, and RIVANNA reported that per-volume label prediction accuracy, a measure of anatomical labeling, ranged from 95.1% to 100.0%.
Separate from the validation supporting the BoneEnhance clearance, the company cited peer-reviewed evidence for the platform’s automated acquisition. In a study of 205 patients published in the Journal of Emergency Medicine, operators with one hour of hands-on training acquired wrist and ankle images rated adequate for diagnostic interpretation in more than 90% of scans, with image quality comparable to physician-acquired scans. RIVANNA’s earlier clearance announcement states that the study was conducted at UVA Health and UT Southwestern Medical Center and that it compared non-physician operators with board-certified emergency physicians.
Study Growth and the Injury Detection Module
The clinical study behind BoneEnhance has continued to grow. RIVANNA announced in April 2026 that the study had expanded from two sites to eight — Denver Health, Texas Tech Health El Paso, the University of California, San Francisco, the University of Utah, UVA Health, UT Southwestern Medical Center, Virginia Commonwealth University, and Yale University — after the Biomedical Advanced Research and Development Authority (BARDA) executed a funding option. At that stage, the program was training CADe/x, which RIVANNA describes as the first computer-aided detection algorithm for automated fracture identification derived from volumetric ultrasound imaging, and completing validation of BoneEnhance.
According to the new release, the study has since expanded from eight to ten sites and is building the datasets used to train an investigational musculoskeletal injury detection module for the Accuro XV. Where BoneEnhance labels anatomy, the investigational module is being developed to assist clinicians in evaluating potential extremity fractures within acquired ultrasound images. The release states that because the sites and data infrastructure were established once and are reused for each new module, every subsequent module builds on the program’s federal investment.
Delphine Le Roux, RIVANNA’s senior director of market access and strategic partnerships, credited the participating clinical sites and BARDA’s sustained support for the evidence program behind the clearance. “The infrastructure, partnerships, and regulatory playbook we established for BoneEnhance are designed to carry forward,” she said.
The project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and BARDA, under contract number 75A50121C00035.
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