Raydiant Oximetry has completed enrollment and data collection for the first 15 patients in its FDA-approved IDE pilot study at LSU Health Shreveport, advancing development of its fetal pulse oximetry technology.
The study evaluates Raydiant’s investigational transvaginal fetal oxygen sensor, designed to measure fetal oxygen levels during active labor. Data collected from the first patients — more than 40 hours of recordings — will support the development and optimization of the company’s machine learning algorithms.
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Following a review of the initial data, the FDA approved expansion of the study to include up to 30 patients, allowing Raydiant and LSUHS to continue building the clinical dataset.
Dr. P. Scott Barrilleaux, principal investigator at LSUHS, said:
“We continue to believe in the potential clinical value that fetal pulse oximetry can bring to labor and delivery…”
Raydiant CEO Michael Nagel added:
“The FDA’s authorization to expand enrollment is an important milestone for the program.”
The study represents a key step toward developing next-generation fetal monitoring technologies using advanced biophotonics and artificial intelligence.
