Medtronic, a global leader in healthcare technology, announced verification study results for its investigational Nellcor™ pulse oximetry with Nell-EQ™ intelligent processor at the Society for Technology in Anesthesia (STA) Annual Meeting.

美敦力公司，全球医疗技术的领导者，在麻醉技术学会（STA）年会上宣布了其研究中的Nellcor™脉搏血氧仪配备Nell-EQ™智能处理器的验证研究结果。

The company successfully completed pivotal clinical studies for its new Nellcor™ pulse oximetry technology. Initial data show that the investigational Nell-EQ™ intelligent processor technology, when paired with a set of market-released sensors representative of the Nellcor™ pulse oximetry sensor line, demonstrated SpO₂ accuracy better than the FDA’s draft-recommended.

该公司成功完成了其新的Nellcor™脉搏血氧仪技术的关键临床研究。初步数据显示，当研究中的Nell-EQ™智能处理器技术与代表Nellcor™脉搏血氧仪传感器系列的一组已上市传感器配合使用时，其SpO₂精度优于FDA草案推荐的标准。

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threshold. Additionally, pulse rate accuracy was within Nellcor™ technology acceptance limits. These results were observed in a sample inclusive of the full range of skin tones.

阈值。此外，脉搏率的准确性在Nellcor™技术的可接受范围内。这些结果是在包含全部肤色范围的样本中观察到的。

Pulse oximetry accuracy has historically varied across skin tones, raising concerns about technology that works for all patients. The investigational Nell-EQ™ intelligent processor technology reflects ongoing efforts of Medtronic to deliver its Nellcor™ technology’s consistent SpO₂ and pulse rate accuracy across all skin tones.

脉搏血氧仪的准确性历来因肤色不同而有所差异，这引发了对适用于所有患者的技术的担忧。实验性的Nell-EQ™智能处理器技术体现了美敦力公司持续努力，旨在使其Nellcor™技术在各种肤色中均能提供始终如一的SpO₂和脉率准确性。

The company’s commitment to getting it right — for every patient — is why Medtronic .

公司致力于为每位患者做到正确，这就是美敦力公司的原因。

opened a clinical physiology lab

开设了一个临床生理学实验室

near the Five Points neighborhood of Denver, Colorado. As a result of their extensive community outreach efforts, Medtronic has conducted its clinical studies not only with a diverse array of participants but with greater speed and frequency, leading to faster innovation.

科罗拉多州丹佛市五点街区附近。由于其广泛的社区推广工作，美敦力不仅以多样化的参与者进行了临床研究，而且速度和频率更高，从而加快了创新。

Previously granted FDA Safer Technologies Program (STeP) designation

之前获得FDA更安全技术计划（STeP）指定

, the company’s investigational Nellcor™ pulse oximetry with Nell-EQ™ intelligent processor is currently under 510(k) review, marking an important regulatory milestone in efforts by Medtronic to bring this innovation to market.†

，该公司正在研发的Nellcor™脉搏血氧仪与Nell-EQ™智能处理器目前正在进行510(k)审查，这标志着美敦力在将这一创新技术推向市场的努力中迈出了重要的监管里程碑。†

“Today’s verification study results demonstrate accuracy across various skin tones, meeting and exceeding both the current U.S. FDA guidance and newer, more-inclusive draft guidance,” said Dr. Randall Clark, principal investigator of the Medtronic clinical physiology lab. “Seeing such positive outcomes with the investigational Nellcor™ pulse oximetry technology, paired with Nellcor™ sensors, marks an important step toward advancing medical-grade pulse oximetry that works for every patient.”.

“今天的验证研究结果展示了在各种肤色上的准确性，不仅符合而且超过了当前美国FDA的指导方针以及更新、更具包容性的草案指南。”美敦力临床生理学实验室的首席研究员兰德尔·克拉克博士说道。“看到这种试验性的Nellcor™脉搏血氧测量技术与Nellcor™传感器配合使用取得如此积极的结果，标志着我们在推进适用于每位患者的医疗级脉搏血氧测量技术方面迈出了重要的一步。”

The verification studies were conducted in consideration of the evolving regulatory guidance

考虑到不断演变的监管指南，进行了验证研究。

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and global standards expectations on pulse oximeters for medical purposes, which recommends accuracy testing across the full spectrum of skin tones and maintaining the upper limit of the 95% confidence interval (CI) for SpO₂ accuracy within 3%, regardless of sensor type.

以及对医用脉搏血氧仪的全球标准期望，该标准建议在所有肤色范围内进行准确性测试，并将SpO₂准确性的95%置信区间（CI）上限保持在3%以内，无论传感器类型如何。

Key findings:

主要发现：

Study design:

研究设计：

Three controlled hypoxia studies with 71 participants (ages 20–46) representing diverse skin tones across

三项可控的低氧研究，共有71名参与者（年龄20-46岁），代表了不同的肤色。

Monk Skin Tone (MST)

和尚肤色 (MST)

cohorts:

队列：

• Light (MST 1–4): 32 participants (45.1%)

• 轻度（MST 1-4）：32 名参与者（45.1%）

• Medium (MST 5–7): 19 participants (26.8%)

• 中等（MST 5-7）：19名参与者（26.8%）

• Dark (MST 8–10): 20 participants (28.2%)

• 黑暗（MST 8-10）：20 名参与者（28.2%）

SpO₂ accuracy:

SpO₂ 精度：

Investigational Nellcor™ pulse oximetry with Nell-EQ™ intelligent processor paired with Nellcor™ sensors demonstrated SpO₂ RMS accuracy ranging from 1.33% (upper 95% CI: 1.48%) to 1.69% (upper 95% CI: 1.93%), outperforming the FDA draft guidance threshold of 3%.

配备Nell-EQ™智能处理器的Nellcor™脉搏血氧仪与Nellcor™传感器配合使用时，显示SpO₂ RMS精度范围从1.33%（上限95%置信区间：1.48%）到1.69%（上限95%置信区间：1.93%），优于FDA草案指南中3%的阈值。

Pulse rate accuracy:

脉搏率精度：

RMS accuracy remained within 2 bpm, meeting the Nellcor™ technology acceptance criterion of 3 bpm.

RMS 精度保持在 2 bpm 以内，符合 Nellcor™ 技术接受标准的 3 bpm。

“Medtronic is leading the way for pulse oximetry technology that aims to deliver accuracy and inclusivity for every patient, every time,” said Dr. Jeb Denny, chief medical officer of the Medtronic Acute Care & Monitoring business, which is part of the company’s Medical Surgical Portfolio. “Our leadership in this space reflects a commitment to advancing standards that represent all patients and empowering clinicians with world-class technology to deliver safe, equitable care for every patient, in every setting.”.

“美敦力公司处于脉搏血氧测量技术的前沿，该技术旨在为每位患者提供准确性和包容性。”美敦力急性护理与监测业务部（隶属于公司医疗外科产品组合）首席医疗官杰布·丹尼博士表示，“我们在这一领域的领导地位反映了我们致力于推动代表所有患者的标准，并通过世界级技术为临床医生赋能，以在各种环境中为每位患者提供安全和平等的护理。”

The findings were presented by Medtronic at STA 2026, with Dr. David MacLeod, anesthesiologist at Duke University Hospital in North Carolina, as the healthcare professional author on the abstract.

这些发现由美敦力公司在STA 2026会议上发布，北卡罗来纳州杜克大学医院的麻醉师大卫·麦克劳德博士为该摘要的医疗专业作者。

Learn more about equitable monitoring and the company’s commitment to patient safety at

了解有关公平监测和公司对患者安全承诺的更多信息，请访问

health equity in pulse oximetry monitoring

脉搏血氧仪监测中的健康公平性

and on

并且继续

Medtronic Academy

美敦力学院

.

。

† STeP designation applies to future product candidates. Nellcor™ technology in the scope of the STeP application is 510(k) pending. It is not approved or cleared by the FDA and not available for sale in the U.S. Inclusion in STeP does not guarantee approval, clearance, or granting of future marketing submissions..

† STeP 指定适用于未来的产品候选者。Nellcor™ 技术在 STeP 申请范围内尚处于 510(k) 待定状态。它未获 FDA 批准或清除，且在美国不可销售。纳入 STeP 并不保证未来的上市申请会获得批准、清除或许可。

Acute Care and Monitoring products should not be used as the sole basis for diagnosis or therapy and are intended only as an adjunct in patient assessment. Note: Oxygen saturation accuracy can be affected by certain environmental, equipment, and patient physiologic conditions that influence readings of SpO2..

急性护理和监测产品不应作为诊断或治疗的唯一依据，仅用作患者评估的辅助工具。注意：氧饱和度的准确性可能会受到某些环境、设备和患者生理状况的影响，这些因素会影响SpO2的读数。

References

参考文献

1. Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations - Draft Guidance for Industry and Food and Drug Administration Staff. 2025.

1. 用于医疗目的的脉搏血氧仪 - 非临床和临床性能测试、标签及上市前提交建议 - 行业和食品药品监督管理局工作人员指南草案。2025。

About Medtronic

关于美敦力

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries.

大胆思考。更果敢的行动。我们是美敦力。美敦力公司总部位于爱尔兰戈尔韦，是全球领先的医疗技术公司，通过寻找并发现解决方案，大胆应对人类面临的最严峻的健康问题。我们的使命——减轻病痛、恢复健康、延长生命——团结了遍布150个国家的95,000多名充满热情的员工。

Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

我们的技术和治疗手段涵盖70种健康状况，包括心脏设备、手术机器人、胰岛素泵、手术工具、患者监测系统等。凭借我们多元化的知识、无尽的好奇心和帮助所有有需要的人的愿望，我们提供了创新的技术，每秒、每小时、每一天都在改变两个人的生活。

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit .

期待我们带来更多精彩，因为我们致力于推动以洞察力为导向的护理、以人为本的体验，以及为世界创造更好的成果。在我们所做的一切中，我们正在创造非凡的工程。欲了解有关美敦力的更多信息，请访问。

medtronic.com

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Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

任何前瞻性陈述都受到风险和不确定性的影响，例如美敦力公司向证券交易委员会提交的定期报告中所述的风险和不确定性。实际结果可能与预期结果有重大差异。

Contacts

联系人

Amanda Bartschenfeld

阿曼达·巴特申费尔德

Communications

通讯

amanda.k.bartschenfeld@medtronic.com

amanda.k.bartschenfeld@美敦力.com

Ingrid Goldberg

英格丽德·戈德堡

Investor Relations

投资者关系

investor.relations@medtronic.com

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