Medtronic, a global leader in healthcare technology, announced today that new Nellcor™ pulse oximetry technology currently in-development has been accepted into the U.S. Food and Drug Administration’s (FDA) Safer Technologies Program (STeP). STeP is an FDA program for medical devices that are reasonably expected to improve the safety of currently available devices.

全球医疗技术领导者美敦力公司今天宣布，其正在开发中的新型Nellcor™脉搏血氧测量技术已被美国食品药品监督管理局（FDA）的更安全技术计划（STeP）接受。STeP是一项针对医疗设备的FDA计划，旨在合理预期能够提高现有设备的安全性。

The program leverages an interactive process with the FDA to support expedited development, assessment, and review of designated investigational devices..

该计划利用与 FDA 的互动流程，以支持指定研究性器械的加快开发、评估和审查。

The investigational Nellcor™ technology aims to integrate patient-specific and sensor-specific data into oxygen saturation calculations used in pulse oximetry. Acceptance to the program was based on Eligibility Criterion 2a, which outlines that the device is reasonably expected to improve the benefit-risk profile and reduce the occurrence of serious adverse events..

这项研究性的Nellcor™技术旨在将患者特定和传感器特定的数据整合到脉搏血氧仪使用的血氧饱和度计算中。项目接纳的依据是资格标准2a，该标准指出该设备有望合理改善收益-风险状况，并减少严重不良事件的发生。

Pulse oximetry measures blood oxygen levels, one of many important vital signs that helps clinicians provide timely care. Pulse oximeters work by sending light through a patient’s finger and measuring its absorption. However, these devices can have blind spots. Melanin, for example, can impact light absorption, potentially leading to unrecognized hypoxemia in patients with darker skin pigmentation..

脉搏血氧仪用于测量血氧水平，这是帮助临床医生提供及时护理的众多重要生命体征之一。脉搏血氧仪通过向患者手指发送光线并测量其吸收情况来工作。然而，这些设备可能存在盲点。例如，黑色素会影响光的吸收，这可能导致肤色较深的患者出现未被识别的低氧血症。

“We appreciate the FDA's designation of Nellcor™ technology currently in-development, which reflects our long-standing commitment to advancing patient safety and clinical confidence in pulse oximetry,” said Samir Ibrahim, senior director of regulatory affairs of the Acute Care and Monitoring business, which is part of the Medical Surgical Portfolio at Medtronic..

“我们非常感谢FDA对我们目前正处于研发阶段的Nellcor™技术的认可，这反映了我们在推进脉搏血氧测量技术方面的长期承诺，提升了患者安全和临床信心，”美敦力医疗手术组合中急性护理与监测业务的监管事务高级总监Samir Ibrahim表示。

While recent evidence shows that today’s Nellcor™ pulse oximeters lead the way in equitable patient monitoring,

尽管最近的证据表明，如今的Nellcor™脉搏血氧仪在公平的患者监测方面处于领先地位，

the company continues to partner and invest in professional education and continued innovation. You can find educational resources on how pulse oximeters work and tips for getting the most accurate SpO₂ readings from current devices at

该公司继续合作并投资于专业教育和持续创新。您可以在以下位置找到有关脉搏血氧仪工作原理的教育资源以及如何从现有设备获取最准确的SpO₂读数的提示：

Medtronic Academy

美敦力学院

. Medtronic remains committed to delivering better outcomes for all patients through continued innovation and are proud to participate in the STeP program.

. 美敦力仍致力于通过持续创新为所有患者提供更好的治疗效果，并为参与STeP计划感到自豪。

About Medtronic

美敦力公司简介

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 more than 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，勇敢地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——将遍布150多个国家的95,000多名充满热情的员工团结在一起。

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.

我们的技术和疗法治疗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。凭借我们广泛的知识、无尽的好奇心和帮助所有需要帮助的人的愿望，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。