SimBioSys, a clinical AI company leveraging spatial biophysics to drive precision in breast cancer treatment, today announced its third FDA 510(k) clearance for TumorSight™ Viz. The clearance expands the platform's ability to convert standard breast MRI into intuitive, 3D visualizations that support more informed and individualized surgical decision-making.

SimBioSys，一家利用空间生物物理学推动乳腺癌治疗精准化的临床AI公司，今日宣布其TumorSight™ Viz平台获得了第三次FDA 510(k)许可。该许可扩展了平台将标准乳腺MRI转化为直观的3D可视化图像的能力，有助于更明智和个性化的手术决策支持。

TumorSight Viz 1.3 builds on the platform's FDA-cleared foundation with new capabilities that significantly improve performance, expand clinical utility, and simplify integration into surgical workflows..

TumorSight Viz 1.3 在该平台获得 FDA 认证的基础上，新增了显著提升性能、扩展临床应用并简化手术流程集成的功能。

'This latest clearance represents a pivotal step forward in our mission to bring greater precision and progress in the fight against breast cancer,' said

“这一最新的批准标志着我们在为抗击乳腺癌带来更大精确性和进展的使命中迈出了关键的一步，”

Stacey Stevens

史蒂西·史蒂文斯

, President and CEO of SimBioSys. 'As the leading cancer diagnosed in women worldwide, breast cancer presents a complex and urgent challenge—demanding tools that enhance surgical clarity and enable more individualized care. TumorSight Viz 1.3 delivers a new level of intelligence and insight, helping surgeons see what's possible with greater confidence and enabling care that's truly aligned with each patient's unique anatomy and goals.'.

SimBioSys总裁兼首席执行官表示：“作为全球女性中最常见的癌症诊断，乳腺癌带来了复杂且紧迫的挑战，需要能够提高手术清晰度并实现更个性化护理的工具。TumorSight Viz 1.3 提供了更高层次的智能和洞察力，帮助外科医生更加自信地看清可能的情况，并实现真正符合每位患者独特解剖结构和目标的护理。”

TumorSight™ Viz

肿瘤视野™ 可视化

1.3 marks

1.3 分

the next evolution of a clinically validated platform, purpose-built to support greater consistency, precision, and efficiency in breast cancer surgery. With its third FDA clearance, TumorSight Viz delivers expanded functionality optimized for broader integration across surgical settings and supported by robust clinical validation.

经过临床验证的平台的下一代演变，专为支持乳腺癌手术中更高的一致性、精确性和效率而打造。凭借其第三次FDA批准，TumorSight Viz提供了扩展的功能，针对更广泛的手术环境整合进行了优化，并得到了强大的临床验证支持。

The latest release introduces:.

最新版本引入了：。

Superior AI-Driven Segmentation

卓越的AI驱动分割

– Industry-leading accuracy in lesion segmentation and tumor volume estimation, enabling greater confidence in preoperative planning.¹

– 在病灶分割和肿瘤体积估算方面具有行业领先的准确性，从而在术前规划中提供更高的信心。¹

Faster Case Processing

更快的案件处理速度

– Produces results in minutes, enabling same-day insights that support more timely, informed conversations with patients.¹

– 在数分钟内生成结果，提供当日洞察，有助于与患者进行更及时、更明智的对话。¹

Streamlined Workflow Integration

简化的工作流集成

– New PACS connectivity automates image transfer and reduces manual tasks—enhancing efficiency for physicians and staff.¹

– 新的PACS连接性可自动传输图像并减少手动任务，提高医生和工作人员的效率。¹

A growing body of evidence supports TumorSight Viz, with studies demonstrating strong concordance with radiologist annotations, accurate delineation of tumor size relative to breast volume, and consistent performance across more than 1,600 retrospective cases from more than nine institutions—underscoring its readiness to support confident, anatomy-driven surgical care..

越来越多的证据支持TumorSight Viz，研究表明其与放射科医生的注释高度一致，能够准确描绘肿瘤相对于乳腺体积的大小，并在来自九个机构的1600多例回顾性病例中表现稳定——这充分证明了它已准备好为基于解剖结构的自信手术护理提供支持。

'TumorSight Viz 1.3 helps eliminate guesswork in the OR,' said

“TumorSight Viz 1.3有助于消除手术室中的猜测，”

Barry Rosen

巴里·罗森

, MD, FACS, Breast Surgical Oncologist, Chief Medical Officer of SimBioSys. 'This latest version brings a new level of clarity and control to breast cancer surgery—delivering the anatomical insight and intuitive design surgeons have long needed. It empowers us to make more informed decisions about margins, incisions, and reconstruction, and just as importantly, it helps patients visualize their care in a way that fosters trust, understanding, and confidence in the path forward.'.

医学博士，FACS，乳腺外科肿瘤学家，SimBioSys首席医疗官。“这个最新版本为乳腺癌手术带来了更高层次的清晰度和控制力——提供了外科医生长期以来所需的解剖学洞察和直观设计。它使我们能够就手术边缘、切口和重建做出更明智的决策，并且同样重要的是，它帮助患者以一种促进信任、理解和信心的方式可视化他们的治疗路径。”

Rising expectations around surgical precision and cosmetic outcomes are transforming breast cancer care. Re-excision rates remain above 20 percent, underscoring the need for technologies that support more accurate and confident surgical planning.

对手术精确性和美容效果的期望不断提高，正在改变乳腺癌的治疗方式。再次切除率仍然高于20％，凸显了对支持更准确、更有信心的手术规划技术的需求。

Data presented at the 2025 American Society of Breast Surgeons (ASBrS) Annual Meeting revealed significant variability in surgical decisions—even among experienced providers—reinforcing the need for standardized, data-driven approaches.

2025年美国乳腺外科医生协会（ASBrS）年会上展示的数据表明，即使在经验丰富的医生之间，手术决策仍存在显著差异，这进一步凸显了对标准化、数据驱动方法的需求。

The National Comprehensive Cancer Network (NCCN) supports this shift with updated guidelines that emphasize evidence-based strategies for reconstruction and oncoplastic procedures.

美国国家综合癌症网络（NCCN）通过更新指南支持这一转变，强调基于证据的重建和肿瘤整形手术策略。

TumorSight Viz helps close this gap by converting complex MRI data into clear, anatomy-specific insights—enabling surgeons to operate with greater consistency and personalization.

TumorSight Viz 通过将复杂的核磁共振成像数据转化为清晰的、特定解剖结构的见解来缩小这一差距，使外科医生能够更一致且个性化地进行手术。

'With our third FDA clearance, growing clinical evidence, and alignment with modern standards of care, TumorSight Viz is setting a new benchmark for AI-powered surgical visualization in breast cancer,' added Ms. Stevens. 'We're proud to partner with clinicians who are driving progress in the OR every day—and remain committed to delivering solutions that enhance precision, enable shared decision-making, and ultimately support improved outcomes for patients nationwide.'.

“随着我们的第三次FDA批准、越来越多的临床证据，以及与现代护理标准的契合，TumorSight Viz正在为乳腺癌手术可视化中的人工智能设立一个新的标杆，”史蒂文斯女士补充道。“我们很自豪能与每天在手术室推动进步的临床医生合作，并且我们依然致力于提供能够提高精确性、实现共同决策并最终支持全国患者改善结果的解决方案。”

About SimBioSys

关于SimBioSys

SimBioSys is a clinical AI company leveraging spatial biophysics to drive precision in breast cancer treatment. By revolutionizing how cancer is understood and treated, SimBioSys is empowering clinicians with greater clarity, consistency, and confidence to deliver care aligned with each patient's unique needs.

SimBioSys是一家临床人工智能公司，利用空间生物物理学推动乳腺癌治疗的精准性。通过革新对癌症的理解和治疗方法，SimBioSys为临床医生提供了更清晰、一致和自信的能力，以提供符合每位患者独特需求的护理。