# Advancing Fetal Assessment during Labor with Transabdominal Fetal Oximetry

> **NIH NIH R44** · RAYDIANT OXIMETRY, INC. · 2024 · $871,669

## Abstract

Project Abstract
Raydiant Oximetry, Inc. (Raydiant) has developed and patented a novel optical-sensing technology (‘LumerahTM’)
to directly assess fetal status during labor and delivery through non-invasive, transabdominal measurement of fetal
oxygenation. This technology will allow clinicians to directly monitor intrapartum fetal oxygenation. There are
serious and significant limitations in the use of electronic fetal heart rate monitoring by cardiotocography (CTG) for
monitoring fetal status during labor and detection of fetal compromise due to hypoxia. Owing to misinterpretation
and inherent limitations of CTG, there is an intolerably high false positive rate (89%) for detecting fetal hypoxemia
that has resulted in high rates of medically unnecessary cesarean deliveries. Cesarean delivery is not benign; it has
potential adverse consequences for mothers and newborns and incurs substantial unnecessary healthcare cost.
Furthermore, CTG false negatives, when fetal hypoxia is unrecognized owing to misinterpretation of CTG, result in
devastating neonatal consequences, such as hypoxic ischemic encephalopathy that also incurs substantial
healthcare cost. Monitoring fetal oxygenation in conjunction with CTG will provide a more precise modality of fetal
surveillance during labor and delivery, safely reduce the use of medically unnecessary cesarean deliveries, and
reduce the occurrence of newborns suffering consequences of metabolic acidosis
In prior studies, supported by SBIR Phase I & II awards, Raydiant Oximetry: (i) developed computational models of
fetal and maternal tissues in 2D and 3D to inform hardware design, algorithm development and feature set
extraction; (ii) obtained first-in-human feasibility data in a clinical study of 6 pregnant women to validate the
computational modeling efforts (clinicaltrials.gov: NCT04081623); and (iii) validated the approach with preclinical
studies in the pregnant ewe model.
The proposed Phase II SBIR builds directly upon these results. The goals of this research are to advance this
technology towards commercialization by collecting human data training sets to refine the computational algorithm
that allows separation of the fetal from maternal near infrared signals and then validate this algorithm to support
an upcoming IDE filing with the FDA.
This Phase II SBIR application is in response to the Notice of Special Interest (NOT-HD-21-053) from the NICHD to
advance the development of non-invasive, physiological monitors that improve fetal assessment through the non-
invasive measurement of fetal blood pH or oxygenation.

## Key facts

- **NIH application ID:** 10934515
- **Project number:** 5R44HD094486-03
- **Recipient organization:** RAYDIANT OXIMETRY, INC.
- **Principal Investigator:** Neil Padharia Ray
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $871,669
- **Award type:** 5
- **Project period:** 2018-07-15 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10934515

## Citation

> US National Institutes of Health, RePORTER application 10934515, Advancing Fetal Assessment during Labor with Transabdominal Fetal Oximetry (5R44HD094486-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10934515. Licensed CC0.

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