Validating novel optical-sensing technology for transabdominal fetal oximetry through pregnant ewe animal models.

Raydiant Oximetry, Inc., Mountain View CA

Investigators

Abstract

Project Abstract Raydiant Oximetry, Inc. has developed and patented novel optical-sensing technology for non-invasive, trans-abdominal fetal oximetry on pregnant women with the hypothesis that this new technology can be more reliable for detecting fetal distress. The current technology used to monitor fetal distress during labor & delivery is known as fetal heart rate monitoring (FHR) and this technology is associated with an 89% overall false positive rate for detecting fetal distress and a 99% false positive rate for detecting fetal distress in category II fetal heart rate tracings. Clearly there is an opportunity for improvement in fetal monitoring market. The aims of this project will be to determine how deep a fetal signal can be obtained and which body part of the fetus provides the strongest signal by developing software algorithms for real-time calculation of fetal oxygen saturation as well as a real-time indicator of fetal signal strength. Furthermore, we will validate our real time calculations by testing the optical-sensing technology on a pregnant ewe model and correlating the oxygen saturation calculations with blood gas measurement. The data obtained from this Phase 1 SBIR project will be utilized to develop a Phase 2 proposal to initiate a clinical study for feasibility during labor & delivery on pregnant human subjects. The successful completion of this Phase 1 effort will be an important milestone that de-risks the technology feasibility and leads to the development of a viable medical device with commercialfeasibility.