GE HealthCare and Raydiant Oximetry accelerate innovation in fetal oxygen saturation technology

GE HealthCare and Raydiant Oximetry announced a joint development initiative to enhance fetal monitoring capabilities that could strengthen the support of clinical decision-making during labour. This effort leverages the combined expertise and technology of the two companies to advance fetal oxygen saturation monitoring technology with the goal of enhancing the detection of fetal distress during childbirth.

Incorporating oxygen saturation into fetal monitoring can help improve measurements of fetal distress and enhance clinician confidence when making critical decisions during labour by providing a more comprehensive view of fetal well-being. Additionally, improving clinicians’ evaluation of fetal status may help reduce emergency cesarean section rates, which have been steadily increasing worldwide over the last few decades beyond levels considered medically necessary.

Raydiant Oximetry has developed fetal pulse oximetry solutions to improve the detection of fetal distress during childbirth by measuring fetal blood oxygen saturation. In initial preclinical and clinical studies, Raydiant Oximetry has demonstrated that fetal pulse oximetry could improve the sensitivity and specificity for detecting fetal distress during labour and delivery, and potentially reduce newborn neurological injury rates, emergency cesarean section delivery rates and healthcare costs associated with childbirth.

Raydiant Oximetry has received United States Food and Drug Administration (FDA) Breakthrough Device Designation for expedited review by the FDA, and FDA approval for an Investigational Device Exemption (IDE) to conduct an Early Feasibility Study (EFS) of 30 pregnant women during labour and delivery. The initiation of the GE HealthCare and Raydiant Oximetry effort follows the completion of the EFS IDE clinical study.

Through this initiative, the companies plan to co-develop solutions that support the integration of Raydiant Oximetry’s fetal pulse oximetry technology into GE HealthCare’s fetal monitoring and digital perinatal surveillance platforms. The terms of the agreement have not been disclosed.