Raydiant Oximetry Inc. has received U.S. Food and Drug Administration (FDA) approval for an Investigational Device Exemption (IDE) Early Feasibility Study (EFS) of its Lumerah technology.

Raydiant Oximetry Inc.已获得美国食品和药物管理局（FDA）对其Lumerah技术的研究设备豁免（IDE）早期可行性研究（EFS）的批准。

Lumerah is a non-invasive, transabdominal fetal pulse oximeter designed to improve the detection of fetal distress during labor and delivery by measuring the fetal blood oxygen saturation. The current standard of care is fetal heart rate (CTG) monitoring, but this technology has low sensitivity and low specificity for detecting fetal distress.1.

Lumerah是一种非侵入性经腹胎儿脉搏血氧仪，旨在通过测量胎儿血氧饱和度来改善分娩和分娩期间胎儿窘迫的检测。目前的护理标准是胎心率（CTG）监测，但该技术检测胎儿窘迫的灵敏度低，特异性低。

Low sensitivity leads to unrecognized fetal distress and newborn neurological injury from oxygen deprivation during birth. “Each year 36,000 babies in the United States suffer neurological damage, which could be prevented through better monitoring tools, such as Lumerah,” Raydiant Oximetry Founder/CEO Neil P.

低敏感性导致出生时缺氧导致无法识别的胎儿窘迫和新生儿神经损伤。Raydiant Oximetry创始人/首席执行官NeilP。

Ray, M.D., said..

医学博士雷说。。

Low specificity leads to the overuse of emergency C-sections deliveries and adds risks to both mother and baby while increasing healthcare costs. “While C-sections are the most commonly performed major surgery, with 1.2 million annually, nearly half of them are medically unnecessary. Current fetal monitoring techniques play a large role in these emergency surgeries and have a lasting impacts on babies and mothers,” Ray noted. .

低特异性导致过度使用紧急剖腹产，并增加了母亲和婴儿的风险，同时增加了医疗保健成本。雷指出：“虽然剖腹产是最常进行的大手术，每年有120万例，但其中近一半在医学上是不必要的。目前的胎儿监护技术在这些紧急手术中发挥着重要作用，并对婴儿和母亲产生了持久的影响。”。。

Initial preclinical and clinical studies suggest that Lumerah could significantly improve the sensitivity and specificity for detecting fetal distress and reduce newborn neurological injury as well as emergency C-sections deliveries. Lumerah has received FDA Breakthrough Device Designation for expedited market approval.2.

最初的临床前和临床研究表明，Lumerah可以显着提高检测胎儿窘迫的敏感性和特异性，减少新生儿神经损伤以及紧急剖腹产。Lumerah已获得FDA突破性设备指定，以加快市场批准。

The IDE study will begin at Eastern Virginia Medical School (EVMS) in Norfolk, Va., under the direction of Dr. George Saade, chair of Obstetrics & Gynecology, associate dean for Women’s Health at EVMS and editor-in-chief of the American Journal of Perinatology. “I believe Lumerah could have a transformative impact on the intrapartum care of mothers and babies, and we are excited to initiate this study under the FDA IDE,” Dr.

IDE研究将在弗吉尼亚州诺福克的东维吉尼亚医学院（EVMS）开始，由妇产科主席、EVMS妇女健康副院长、《美国围产期杂志》主编乔治·萨德博士指导。“我相信Lumerah可能会对母亲和婴儿的产时护理产生变革性影响，我们很高兴在FDA IDE下启动这项研究，”Dr。

Saade stated. The EFS study will help move Raydiant Oximetry along the path to FDA IDE approval for a subsequent pivotal study..

萨阿德表示。EFS研究将有助于将Raydiant血氧仪沿着FDA IDE批准的道路进行后续的关键研究。。

Raydiant Oximetry is supported by leading organizations that include the March of Dimes and the National Institutes of Health (NIH). 'Improving maternal and infant health outcomes in the U.S. is our priority at March of Dimes. Our investments through our Innovation Fund helps advance new solutions like Raydiant’s Lumerah product, which we hope will help obstetric care providers when making decisions during labor and delivery,” March of Dimes President/CEO Dr.

Raydiant血氧饱和度测定法得到了领先组织的支持，这些组织包括the March of Dimes和National Institutes of Health（NIH）。'改善美国孕产妇和婴儿健康状况是我们在三月十美分的首要任务。我们通过创新基金的投资有助于推进新的解决方案，如Raydiant的Lumerah产品，我们希望这将有助于产科护理提供者在分娩和分娩过程中做出决策，”March of Dimes总裁/首席执行官Dr。

Elizabeth Cherot said. 'We are encouraged to see the FDA approve the IDE and look forward to the results from the upcoming clinical study at EVMS.'.

伊丽莎白·切洛特说我们很高兴看到FDA批准了IDE，并期待着即将在EVMS进行的临床研究的结果。”。

The Lumerah IDE study at EVMS is supported from a Phase II SBIR grant from Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) of the NIH. “This support is critical, as there has been a lack of funding and innovation in the maternal and female space,” Ray said. “While there are over 800 breakthrough devices, only four—one of which is Raydiant—are in obstetrics.

EVMS的Lumerah IDE研究得到了美国国立卫生研究院EuniceKennedyShriver国家儿童健康与人类发展研究所（NICHD）的第二阶段SBIR资助。雷说：“这种支持至关重要，因为母婴领域缺乏资金和创新。”。“虽然有800多种突破性设备，但只有四种是产科的Raydiant。

Women have largely been ignored, and we are excited to be on the forefront of this sea of change.”.

女性在很大程度上被忽视了，我们很高兴能站在这片变革之海的最前沿。”。

Raydiant Oximetry is a venture-backed, clinical-stage company dedicated to improving outcomes for mothers and babies during childbirth. The company was founded by Ray, a pediatric anesthesiologist, to find a solution to the pervasive problem of identifying fetal distress and potentially avoiding medically unnecessary C-sections.

Raydiant Oximetry是一家由风险投资支持的临床阶段公司，致力于改善分娩期间母亲和婴儿的结局。该公司是由儿科麻醉师Ray创建的，目的是找到一种解决方案，以解决识别胎儿窘迫并可能避免医学上不必要的剖腹产的普遍问题。

Lumerah is an investigational medical device that is not currently approved for commercial sale. .

Lumerah是一种研究性医疗器械，目前尚未批准用于商业销售。。