Michael Barbella, Managing Editor05.23.24
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.
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
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. Saade stated. The EFS study will help move Raydiant Oximetry along the path to FDA IDE approval for a subsequent pivotal study.
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. 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."
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. Women have largely been ignored, and we are excited to be on the forefront of this sea of change.”
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. Lumerah is an investigational medical device that is not currently approved for commercial sale.
References
1 Low JA et al. Predictive value of electronic fetal monitoring for intrapartum fetal asphyxia with metabolic acidosis. PMID: 9932571
2 https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
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
- 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. Ray, M.D., said.
- 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.
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. Saade stated. The EFS study will help move Raydiant Oximetry along the path to FDA IDE approval for a subsequent pivotal study.
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. 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."
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. Women have largely been ignored, and we are excited to be on the forefront of this sea of change.”
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. Lumerah is an investigational medical device that is not currently approved for commercial sale.
References
1 Low JA et al. Predictive value of electronic fetal monitoring for intrapartum fetal asphyxia with metabolic acidosis. PMID: 9932571
2 https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program