Raydiant Oximetry, Inc. announces that the United States Food and Drug Administration (FDA) has approved the Investigational Device Exemption (IDE) of the Lumerah™ technology for an Early Feasibility Study (EFS) of pregnant women during labor and delivery.
SAN RAMON, Calif., April 10, 2024 (GLOBE NEWSWIRE) -- Raydiant Oximetry, Inc., a clinical-stage medical device company that develops medical technologies to improve outcomes for mothers and babies during childbirth, announces that the United States Food and Drug Administration (FDA) has approved the Investigational Device Exemption (IDE) of the Lumerah™ technology for an Early Feasibility Study (EFS) of pregnant women during labor and delivery.
Lumerah is a non-invasive, transabdominal fetal pulse oximeter that was developed 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,” says Raydiant Oximetry founder and CEO, Dr. Neil P. Ray.
- 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,” says Ray.
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
The IDE study will begin in April 2024 at Eastern Virginia Medical School (EVMS) in Norfolk, Virginia under the direction of Dr. George Saade, Chair of Obstetrics & Gynecology, Associate Dean for Women’s Health at EVMS and the Editor-in-Chief for 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,” said Dr. Saade. Completion of the EFS study will pave the path towards 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 US 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,” says Dr. Elizabeth Cherot, March of Dimes President and CEO. “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 under Award Number R44HD094486. “This support is critical, as there has been a lack of funding and innovation in the maternal and female space,” says Ray. “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.”
About Raydiant Oximetry, Inc.
Raydiant Oximetry is a venture-backed, clinical-stage company dedicated to improving outcomes for mothers and babies during childbirth. The company was founded by Neil P. Ray, MD, a pediatric anesthesiologist, to find a solution to the pervasive problem of identifying fetal distress and potentially avoiding medically unnecessary C-sections, which can have short- and long-term implications for the mother and child. Lumerah™ is an investigational medical device that is not currently approved for commercial sale. Learn more: Raydiantoximetry.com.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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
Birgit Johnston Email: birgitjohnston@me.com
