SBIR Phase II: Optimization of non-invasive fetal oxygenation sensing hardware and algorithm

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is translation of a novel, non-invasive monitor for fetal health during labor and delivery that will improve care and reduce cost. Currently, clinicians rely on monitor technologies that are subjective, unreliable and have high false positive rates for detecting the fetus at risk of hypoxia (fetal distress), resulting in high rates of medically unnecessary cesarean deliveries. When medically unnecessary, intervention by cesarean delivery incurs avoidable healthcare cost, unwarranted maternal risk and adverse consequences for newborns. Further, misdiagnosis of fetal health with current technologies results in costly medical negligence litigation. Fetal pulse oximetry would be applicable to over 3 million births per year in the United States alone. This project will advance a new technology to measure oxygen in the fetus's pulse, creating a new method to ensure health of mother and child during delivery. This Small Business Innovation Research (SBIR) Phase II project advances a new safe, non-invasive, reflectance-based optical method for transabdominal fetal pulse oximetry. This method detects the fetal signal at the surface of the maternal abdomen and extracts it from the combined maternal-fetal signal. This project will conduct verification and validation tests to integrate signal processing, biophotonics, and pulse oximetry. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.