Raydiant Oximetry announced that the FDA granted investigational device exemption (IDE) to its Lumerah technology.
IDE enables an early feasibility study evaluating the technology for pregnant women during labor and delivery. The company designed Lumerah to improve the detection of fetal distress during labor and delivery. A non-invasive, transabdominal fetal pulse oximeter, it measures the fetal blood oxygen saturation.
According to a news release, the current standard of care is fetal heart rate (CTG) monitoring. However, Raydiant says this option has low sensitivity and low specificity for detecting fetal distress.
San Ramon, California-based Raydiant says 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. The system already has FDA breakthrough device designation.
Raydiant plans to begin its IDE study this month at Eastern Virginia Medical School (EVMS) in Norfolk, Virginia.
The IDE study will begin in April 2024 at Eastern Virginia Medical School (EVMS) in Norfolk, Virginia.
“This support is critical, as there has been a lack of funding and innovation in the maternal and female space,” said founder and CEO, Dr. Neil P. 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.”