Raydiant Oximetry Completes Enrollment of First 15 Patients in IDE Pilot Study at LSU Health Shreveport

SAN RAMON, Calif., June 15, 2026 /PRNewswire/ -- Raydiant Oximetry, Inc., a clinical-stage medical device company pioneering innovations in fetal pulse oximetry through advanced biophotonics and machine learning, announced today the completion of enrollment and data collection for the first 15 patients in its Investigational Device Exemption (IDE) Pilot Study at Louisiana State University Health Shreveport (LSUHS).

The study is designed to collect fetal pulse oximetry data using Raydiant's investigational transvaginal sensor, which is positioned on the fetus's cheek during active labor. The company has collected more than 40 hours of data from the first 15 patients, providing valuable insights to support the development and optimization of the machine learning algorithms that will power Raydiant's commercial products.

"We have been pleased with our involvement in this clinical study," said Dr. P. Scott Barrilleaux, Associate Professor of Obstetrics & Gynecology at LSUHS and Principal Investigator for the study. "We continue to believe in the potential clinical value that fetal pulse oximetry can bring to labor and delivery and look forward to contributing to the advancement of this important technology."

Following a review of data from the initial patient cohort, the U.S. Food and Drug Administration (FDA) approved an expansion of the study, allowing enrollment of up to 30 patients. Raydiant and LSUHS will continue enrolling patients to further expand the fetal pulse oximetry dataset and support ongoing product development efforts.

"LSUHS has been an outstanding clinical partner and has helped us generate a substantial amount of data during the first phase of this IDE study," said Michael Nagel, Chief Executive Officer of Raydiant Oximetry. "The FDA's authorization to expand enrollment is an important milestone for the program. We look forward to continuing our collaboration with LSUHS as we build the clinical and technical foundation for an entirely new generation of fetal monitoring technologies."

About Raydiant Oximetry, Inc.

Raydiant Oximetry is a venture-backed, clinical-stage medtech company. Founded by pediatric anesthesiologist Neil P. Ray, MD, and incubated at Fogarty Innovation, Raydiant is pioneering fetal pulse oximetry technologies to elevate the standard of care for fetal monitoring in labor and delivery—an area that has seen no meaningful innovation in decades.

While traditional fetal heart rate monitoring is sensitive and detects heart rate changes that may signal distress, it has low specificity, meaning it does not reliably predict whether a fetus is truly hypoxic (low in oxygen). By complementing existing monitoring methods, Raydiant's technology aims to provide clearer insights into fetal oxygen status and well-being.

Learn more at raydiantoximetry.com.

Contact: Denise Malvehy

Email: [email protected]

About LSU Health Shreveport

LSU Health Shreveport is one of two health sciences centers of the Louisiana State University (LSU) System and home to the only academic medical center in a 150-mile radius. The primary mission of LSU Health Shreveport is to teach, heal and discover in order to advance the well-being of the state, region and beyond. LSU Health Shreveport encompasses the School of Medicine, School of Graduate Studies and School of Health Professions and Sciences, Graduate Medical Education (GME), and a robust research enterprise.

For more information, visit www.lsuhs.edu.

SOURCE Raydiant Oximetry