Raydiant Oximetry has completed enrolment and data collection for the initial 15 patients in its pilot study at Louisiana State University Health Shreveport (LSUHS), US.
The investigational device exemption (IDE) study aims to obtain data on foetal pulse oximetry with Raydiant’s investigational transvaginal sensor that is positioned on the foetus’ cheek at the time of active labour.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
More than 40 hours of foetal data have been recorded from this cohort.
Data gathered from the first patients are intended to support further development and optimisation of the machine learning algorithms underpinning Raydiant’s commercial products.
The company and its partners at LSUHS plan to use these insights to enhance their foetal monitoring technology.
LSUHS obstetrics and gynaecology associate professor and study principal investigator Dr Scott Barrilleaux said: “We have been pleased with our involvement in this clinical study.
“We continue to believe in the potential clinical value that foetal pulse oximetry can bring to labour and delivery and look forward to contributing to the advancement of this important technology.”
After reviewing data from the initial patient group, the US Food and Drug Administration (FDA) authorised the study expansion to include up to 30 patients.
Raydiant Oximetry and LSUHS will continue enrolment to broaden the foetal pulse oximetry dataset and support product development.
Raydiant Oximetry CEO Michael Nagel said: “LSUHS has been an outstanding clinical partner and has helped us generate a substantial amount of data during the first phase of this IDE study.
“The FDA’s authorisation to expand enrolment is an important milestone for the programme. We look forward to continuing our collaboration with LSUHS as we build the clinical and technical foundation for an entirely new generation of foetal monitoring technologies.”
In April 2024, Raydiant Oximetry secured an IDE from the FDA for its Lumerah technology, allowing an early feasibility study on pregnant women during labour and delivery.
