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.”