Proprio获得全球首个 AI手术指导平台的 FDA认证-动脉网

Proprio Receives FDA Clearance For the World's First AI Surgical Guidance Platform

CISION 等信源发布 2025-04-08 20:59

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Real-Time Measurement and Guidance Set to Transform Surgery, Starting With World-Renowned Spine Centers Duke Health and UW Medicine

实时测量和引导系统即将变革手术，首先从世界知名的杜克健康中心和UW医学脊柱中心开始。

SEATTLE

西雅图

，

April 8, 2025

2025年4月8日

/PRNewswire/ --

/美通社/ --

Proprio

自身

, the global leader in AI-powered surgical technology, today announced that its AI guidance platform for surgery, Paradigm, has received its second major 510(k) clearance from the U.S. Food and Drug Administration (FDA) to include intraoperative measurements. This is the first-ever technology that enables 3D, dynamic and segmental viewing of the anatomy, and marks the first time in history that surgeons will be able to measure success in real-time during surgery..

，全球人工智能手术技术的领导者，今天宣布其用于手术的AI指导平台Paradigm已获得美国食品药品监督管理局（FDA）的第二次重要510(k)许可，以包括术中测量功能。这是首个能够实现解剖结构的3D、动态和分段显示的技术，并且标志着历史上首次外科医生能够在手术过程中实时测量成功指标。

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Intro to Proprio

Proprio简介

This milestone underscores the growing adoption of AI-driven surgical guidance among leading institutions, including

这一里程碑突显了包括领先机构在内的越来越多的机构采用人工智能驱动的手术指导，

Duke Health

杜克健康

. '

。'

Duke

公爵

continues to advance surgical innovation and utilize cutting-edge technologies to improve outcomes for our patients,' said

继续推进外科创新，并利用尖端技术来改善患者的治疗效果，”他表示。

Christopher I. Shaffrey

克里斯托弗·I·沙弗里

, M.D., neurosurgeon and orthopedic surgeon at Duke Health and member of Proprio's medical advisory board. 'Our use of real-time 3D visualization enables us to measure critical outcomes like spinal alignment during procedures and reduces radiation exposure for operating teams.'

，杜克健康中心的神经外科医生和骨科医生，同时也是Proprio医学顾问委员会成员。 “我们使用实时3D可视化技术能够测量手术过程中的关键结果，如脊柱对齐情况，并减少手术团队的辐射暴露。”

Prior to this clearance, surgeons were not able to easily measure progress to their goals during surgery. To take measurements during a procedure, doctors would have to scrub out and back in between taking X-rays and CT scans, leading to significant delays while patients were under anesthesia and losing blood.

在此清除之前，外科医生无法在手术过程中轻松测量进展以实现其目标。为了在手术过程中进行测量，医生必须在拍摄X光片和CT扫描之间反复洗手和重新消毒，这导致患者在麻醉状态下大量失血并造成显著延迟。

As a result, surgeons would commonly choose to keep surgery moving without delay and had to rely on preoperative measurements for planning and postoperative measurements to determine if they achieved their goals. .

因此，外科医生通常会选择保持手术不间断地进行，并且必须依靠术前测量来规划手术，依靠术后测量来确定他们是否达到了目标。

'We've been using navigation in spine surgery for a while, but what this technology allows us to do is precisely find the right angle without intraoperative radiation and navigate it,' says Dr.

“我们已经在脊柱手术中使用了一段时间的导航技术，但这项技术允许我们做的是精确找到正确的角度，而无需术中辐射，并对其进行导航，”博士说。

Rick Bransford

里克·布兰斯福德

, a

，一个

UW Medicine

华盛顿大学医学院

orthopedic surgeon at Harborview Medical Center. 'The system can kind of tell us the trajectory and guidance to place screws with zero radiation. This is a big deal, as almost all other forms of navigation require some component of intraoperative radiation. This next generation will also allow us to measure real-time change in segmental alignment without intraoperative radiation. This means that not only can we ideally do a better job taking care of patients, but we can also better train our medical students, residents, fellows, and the next generation of surgeons,' Bransford said..

Harborview医疗中心的骨科医生Bransford表示：“该系统可以告诉我们螺钉置入的轨迹和引导信息，且无需辐射。这是一个重大突破，因为几乎所有的其他导航形式都需要一定程度的术中辐射。下一代技术还将使我们能够在没有术中辐射的情况下测量节段对齐的实时变化。这意味着我们不仅可以更好地照顾患者，还可以更好地培训我们的医学生、住院医生、研究员以及下一代外科医生。”

Now, the Paradigm AI platform shares real-time progress against pre-operative plans with continuous, accurate measurements, and lets surgeons know when they have achieved their goals. Using real-time data to inform decisions during surgery can save patients from several more revision surgeries and significantly improve outcomes altogether..

现在，Paradigm AI 平台会根据术前计划实时分享进展，并通过持续、精确的测量让外科医生知道他们何时达成了目标。使用实时数据来指导手术中的决策，可以避免患者接受更多翻修手术，并显著改善整体结果。

'Evolving from highly educated guesswork to data-driven certainty with intraoperative measurements is game-changing,' said

“通过术中测量，从高度依赖经验的猜测转变为数据驱动的确定性，这是一次颠覆性的变革，”

Gabriel Jones

加布里埃尔·琼斯

, CEO and Co-Founder of Proprio. 'Working with the best surgeons, Proprio is reshaping what's possible in surgery and transforming healthcare with AI — not just automating tasks, but improving cognitive calibration, optimizing workflows for operating teams, robotics, and devices, while reducing the risk of adverse events.

，Proprio的首席执行官兼联合创始人。“通过与最优秀的外科医生合作，Proprio正在重塑手术的可能性，并通过人工智能改变医疗保健——不仅仅是自动化任务，而是提高认知校准、优化手术团队、机器人和设备的工作流程，同时降低不良事件的风险。

Our mission is to set a new standard of care that is 10 times more accessible and dramatically improves lives. Giving surgeons the visibility and data they need precisely when they need it is a huge leap forward in achieving our goals.'.

我们的使命是制定一个比现有标准更易于获取的新护理标准，并显著改善人们的生活。在手术医生需要的时候，为他们提供所需的可见性和数据，这是实现我们目标的巨大飞跃。

Proprio's real-time intraoperative measurements add to an unprecedented treasure trove of surgical data. With a comprehensive, multimodal dataset that has a clear view of surgery and is clean, labeled, and continuously refined with surgeon expertise in the loop, Proprio offers the most complete and factual view of surgery — creating new opportunities for training and clinical research.

Proprio的实时术中测量为外科数据宝库增添了前所未有的价值。通过全面的、多模式的数据集，Proprio清晰地展现手术过程，并且数据干净、标注明确，同时在循环中不断由外科医生的专业知识进行优化，从而提供最完整和真实的手术视角——为培训和临床研究创造了新的机会。

Hundreds of the world's greatest spine, neuro, and orthopedic surgeons have already contributed their expertise to Proprio's AI models, creating their digital legacy with every surgery, technique, and outcome recorded for future generations to learn from. .

全球数百位最优秀的脊柱、神经和骨科外科医生已经为Proprio的AI模型贡献了他们的专业知识，通过记录每一次手术、技术和结果，为后代创造了可供学习的数字遗产。

This announcement comes following

这一消息是在以下情况后发布的

Proprio's first FDA clearance

普罗普里奥首次获得FDA批准

for Paradigm.

适用于范式。

About Proprio

关于Proprio

Proprio is the global leader in AI-powered surgical technology. The company's flagship product, the Proprio Paradigm platform, revolutionizes the surgical process by providing AI-guided visualization and data-driven insights that improve precision, efficiency, and patient outcomes. For more information, visit .

Proprio 是全球人工智能手术技术的领导者。该公司的旗舰产品 Proprio Paradigm 平台通过提供人工智能引导的可视化和数据驱动的洞察，彻底改变了手术过程，提高了精确性、效率和患者疗效。欲了解更多信息，请访问。

proprio.ai

普罗普里奥.ai

。

SOURCE Proprio

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