Raydiant Oximetry has secured US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) for its Lumerah technology, allowing an early feasibility study on pregnant women during labour and delivery.
Lumerah is a foetal pulse oximeter, measured using an external single-use photonic sensor. The system was developed to improve the detection of foetal distress during labour and delivery by measuring the blood oxygen saturation of the baby.
Initial preclinical trials have demonstrated that the device is more accurate than foetal heart rate (FHR) monitors, increasing diagnostic accuracy by 80%, as per Raydiant’s website. The FDA has granted breakthrough device status in order to fast-track the market approval of the system.
The Lumerah IDE study is set to begin in April 2024, funded by a Phase II small business innovation research (SBIR) grant from Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institute of Health.
The current standard of care is foetal heart rate (CTG) monitoring, but this technology has low sensitivity and low specificity for detecting foetal distress, highlighted Raydiant in a 10 April statement. This can lead to unrecognised foetal distress and newborn neurological injury due to oxygen deprivation during birth. Additionally, it can lead to the overuse of emergency C-section deliveries posing risks to both mother and baby.
In the announcement accompanying the IDE, Raydiant Oximetry’s CEO, Neil Ray said: “While C-sections are the most commonly performed major surgery, with 1.2 million annually, nearly half of them are medically unnecessary. Current foetal monitoring techniques play a large role in these emergency surgeries and have a lasting impact on babies and mothers.”
According to a GlobalData market model, the pulse oximeter systems market will generate $754m in sales in the US in 2030.
In January 2024, Maternal health company Bloomlife received FDA clearance for its Bloomlife MFM-Pro device, a prescription-based wearable device designed to monitor maternal and foetal heart rates. It can non-invasively measure the body’s electrical activity and uses cloud-based processing to algorithmically extract maternal and foetal heart rates.
In June 2023, the FDA approved Owlet’s BabySat device which uses a wire-free sock design to house pulse oximetry technology that can measure the baby’s heart rate and oxygen saturation levels. If any parameters exceed prescribed ranges, a parent or guardian is alerted via an app.
