Raydiant Oximetry Secures FDA Approval for Lumerah Investigational Device Exemption (IDE) Study

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