Raydiant Oximetry, Inc. has developed and patented novel optical-sensing technology for noninvasive, trans-abdominal fetal pulse oximetry (ROSS: Raydiant Oximetry Sensing System) with the thesis that, with the additional knowledge of fetal oxygenation, clinicians can be more reliably informed about fetal well-being.
There are serious and significant limitations in the use of electronic fetal heart rate monitoring (EFHRM) during labor for detection of fetal oxygen deprivation and prevention of hypoxia-induced injuries of the newborn. Owing to misinterpretation and inherent limitations of EFHRM, there is an intolerably high false positive rate (89%) for detecting fetal hypoxemia.
This results in a high rate of medically unnecessary cesarean deliveries, which have lifelong consequences for mothers and children, and incur substantial unnecessary healthcare cost. Furthermore, the false negative rate of EFHRM results in newborns that suffer from hypoxic injuries such as hypoxic ischemic encephalopathy, a devastating result that also incurs substantial healthcare cost. Monitoring fetal oxygenation, in conjunction with EFHRM, will provide a more precise modality of fetal surveillance during labor and delivery, reduce the use of medically unnecessary cesarean deliveries, and reduce the occurrence of newborns suffering the consequences of metabolic acidosis.
NCC-PDI is structured to provide critical mass for clinical, regulatory, business, scientific, and engineering expertise. Several faculty researchers hold affiliations with both SZI and the Clark School, adding to the Consortium’s wealth of experience in pediatric device development.