RAYDIANT OXIMETRY INC — Department of Health and Human Services SBIR Phase I: NICHD

Description

Project Abstract Raydiant OximetryInchas developed and patented novel optical sensing technology for non invasivetrans abdominal fetal oximetry on pregnant women with the hypothesis that this new technology can be more reliable for detecting fetal distressThe current technology used to monitor fetal distress during labor andampdelivery is known as fetal heart rate monitoringFHRand this technology is associated with anoverall false positive rate for detecting fetal distress and afalse positive rate for detecting fetal distress in category II fetal heart rate tracingsClearly there is an opportunity for improvement in fetal monitoring marketThe 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 strengthFurthermorewe 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 measurementThe data obtained from this PhaseSBIR project will be utilized to develop a Phaseproposal to initiate a clinical study for feasibility during labor andampdelivery on pregnant human subjectsThe successful completion of this Phaseeffort will be an important milestone that de risks the technology feasibility and leads to the development of a viable medical device with commercialfeasibility Project Narrative Raydiant OximetryInchas developed and patented novel optical sensing technology for non invasivetrans abdominal fetal oximetry on pregnant women with the hypothesis that this new technology can be more reliable for detecting fetal distressThis project intends to develop software algorithms for realtime calculation of fetal oxygen saturation as well as a real time indicator of fetal signal strength in order to determine the ideal depth and location for detecting a fetal signalFurthermorewe will validate our real time calculations by testing this optical sensing technology on pregnant ewe models and correlating the calculated fetal oxygen saturation with direct blood gas measurements