/PRNewswire/ -- Sentec, a global leader in non-invasive patient monitoring, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its LuMon™ Electrical Impedance Tomography (EIT) system for premature infant, infant, adolescent, and adult patients—making it the first EIT technology in .

/PRNewswire/ -- 全球非侵入性患者监测领域的领导者Sentec今天宣布，美国食品药品监督管理局（FDA）已授予其LuMon™电阻抗断层成像（EIT）系统510(k)许可，适用于早产儿、婴儿、青少年和成人患者——这使它成为首个获得此项许可的EIT技术。

available for premature infants and for spontaneously breathing patients.

适用于早产儿和自主呼吸的患者。

The LuMon™ EIT System delivers functional lung imaging directly at the NICU bedside—without radiation—helping clinicians better tailor therapy to each patient’s unique needs.

LuMon™ EIT系统可在新生儿重症监护室（NICU）床边直接提供功能性肺部成像——且无辐射——帮助临床医生更好地根据每位患者的不同需求调整治疗方案。

The LuMon™ EIT System delivers functional lung imaging directly at the bedside—without radiation—helping clinicians better tailor therapy to each patient's unique needs.

LuMon™ EIT系统可在床边直接提供功能性肺部成像——且无辐射——帮助临床医生更好地根据每位患者的不同需求调整治疗方案。

Clearance for Premature Infant Use Supports NICU Clinicians to Personalize Ventilatory Care

早产儿使用许可支持新生儿重症监护室医护人员个性化通气护理

While the LuMon™ System can be used to monitor a variety of patients, whether ventilated or spontaneously breathing, the premature infants and other patients in the NICU may stand to benefit the most from EIT's insights at the bedside.

虽然 LuMon™ 系统可用于监测各种患者，无论是使用呼吸机还是自主呼吸的患者，但新生儿重症监护室 (NICU) 中的早产儿和其他患者可能从床旁的电阻抗成像 (EIT) 见解中获益最多。

'Neonatal patients present enormous complexity, especially for ventilation; there's very little room for error, particularly in our smallest patients – and the consequences can follow these babies all their lives,' said Dr.

“新生儿患者的情况非常复杂，尤其是在通气方面；出错的余地非常小，特别是对我们最小的患者而言——其后果可能伴随这些孩子的一生，”博士说道。

David Tingay

大卫·廷盖

, Clinical Neonatologist and Respiratory Physiotherapist at Royal Children's Hospital in

，皇家儿童医院的临床新生儿科医生和呼吸理疗师

Melbourne, Australia

澳大利亚墨尔本

Dr. Tingay

廷盖博士

has done extensive research with the LuMon ™ EIT system in infant patients continued

已经在婴儿患者中对LuMon™ EIT系统进行了广泛的研究并持续进行。

, 'Without EIT, there's been no way for us to continuously see what is happening inside the lungs at the bedside to understand the impact of our interventions better as we perform them.'

“如果没有EIT，我们就无法在床边持续观察肺部内部的情况，以便在实施干预措施时更好地理解其影响。”

The ability to safely visualize lung function at the bedside, continuously and in real time, has enormous potential for guiding neonatal care and, according to Dr. Tingay, 'EIT provides immediate imaging of regional lung function at the bedside. That visualization helps us better understand each patient's respiratory condition and determine the strategies we need to employ for their specific needs.'.

安全地在床边持续实时可视化肺功能的能力对于指导新生儿护理具有巨大潜力，根据Tingay博士的说法，“EIT提供了床边区域肺功能的即时成像。这种可视化帮助我们更好地了解每位患者的呼吸状况，并确定我们需要针对其特定需求采取的策略。”

With the first-ever FDA clearance for premature infants and soft, fabric belts small enough for even very low birthweight infants, the LuMon™ System is positioned to help clinicians deliver gentle and effective respiratory care for the uniquely fragile and complex patients in the NICU.

凭借首个获得FDA批准用于早产儿的系统，以及适合极低出生体重婴儿的柔软织物带，LuMon™ 系统旨在帮助临床医生为NICU中独特脆弱且病情复杂的患者提供温和而有效的呼吸护理。

While the basis of electrical impedance tomography and its use for imaging regional lung function has been present in research for many years, the LuMon™ system is first EIT technology available for routine clinical bedside use with premature infants in

虽然电阻抗断层成像技术的基础及其在局部肺功能成像中的应用已在研究中存在多年，但LuMon™ 系统是首个可用于早产儿常规临床床边监测的EIT技术。

the United States

美国

, and can impact patient care and clinical decision making today.

，并且可以影响当今的患者护理和临床决策。

Learn more about Electrical Impedance Tomography from Sentec

从Sentec了解更多关于电阻抗断层成像的信息

About Electrical Impedance Tomography

关于电阻抗断层成像

Electrical impedance tomography works by sending gentle, alternating currents through the thorax via a comfortable, skin-friendly fabric belt and measuring the resulting voltages to produce dynamic images of regional impedance variations due to breathing. This enables clinicians to evaluate real-time responses to regional ventilation changes such as those resulting from positioning, ventilator settings, and pharmaceuticals, facilitating more precise and individualized care decisions..

电阻抗断层成像技术通过一条舒适、亲肤的织物带在胸部发送温和的交变电流，并测量产生的电压，以生成由于呼吸引起的局部阻抗变化的动态图像。这使临床医生能够实时评估局部通气变化的反应，例如由体位、呼吸机设置和药物引起的变化，从而有助于更精确和个性化的护理决策。

About the LuMon™ System

关于LuMon™系统

Designed for critical care environments, including neonatal, pediatric, and adult intensive care units, the LuMon™ System enables bedside monitoring of regional impedance variations in the thorax to support assessment of a patient's respiratory status. This information assists in the real-time evaluation of air distribution and lung recruitment, supporting timely interventions that may help improve patient outcomes..

专为重症监护环境设计，包括新生儿、儿科和成人重症监护室，LuMon™ 系统能够实现胸腔区域阻抗变化的床旁监测，以支持对患者呼吸状态的评估。该信息有助于实时评估空气分布和肺部复张情况，支持及时干预，可能有助于改善患者预后。

About Sentec

关于Sentec

Sentec is a Swiss-American medical device company specializing in respiratory care. Since its founding in 1999, Sentec utilizes a deep-tech approach that is founded on advanced science and avant-garde technologies for respiratory patients across care areas. Sentec provides healthcare professionals worldwide with non-invasive, continuous monitoring and effective therapeutic solutions..

Sentec是一家瑞士-美国的医疗设备公司，专注于呼吸护理。自1999年成立以来，Sentec采用了一种基于先进科学和前沿技术的深度技术方法，为各护理领域的呼吸系统患者提供服务。Sentec为全球的医疗专业人员提供非侵入性、连续监测和有效的治疗解决方案。