Momentum continues to build for Raydiant Oximetry Inc., a Fogarty Innovation graduate that is redefining maternal and fetal care during childbirth. Founded by pediatric anesthesiologist Dr. Neil P. Ray, Raydiant is delivering promising outcomes with Lumerah, the first-of-its-kind non-invasive fetal pulse oximeter that measures fetal blood oxygen saturation and aims to address the limitations of traditional fetal heart rate monitoring.
Trials yield encouraging outcomes
After receiving FDA Breakthrough Device Designation for expedited review, Raydiant recently concluded an Early Feasibility Study (EFS) of 30 women during labor and delivery at Eastern Virginia Medical School in Norfolk, Virginia. An influential figure in the OBGYN community, Dr. George Saade, Professor and Chair of Obstetrics and Gynecology and the Associate Dean for Women’s Health, served as principal investigator.
The trial offered extremely positive data, showing a 92% sensitivity and a 90% specificity for detecting fetal distress. Low sensitivity can lead to unrecognized fetal distress and newborn neurological injury from oxygen deprivation during birth, and low specificity can result in the overuse of emergency C-section deliveries. Another impressive factor was the 94% “hit rate,” which means that the signal regularly got through and allowed for high-quality results.
An exciting joint development announcement with GE HealthCare
While the study puts them one step closer to extending their reach, another exciting announcement will accelerate the opportunity to bring this crucial device to patients.
In mid-May, GE HealthCare and Raydiant announced a joint development initiative that will directly integrate Raydiant’s technology into GE’s platform monitoring system. “It’s a game changer because it streamlines the cost of customer acquisition and the timeline since we won’t have to sell our own hardware to get the technology into hospitals,” Ray said.
As one of the major players in the fetal monitoring space, GE had been following Raydiant’s progress for several years. When GE Healthcare broke off from the larger GE conglomerate, they deepened their engagement with Raydiant’s solution, Ray explained. They started due diligence in the summer of 2024, eventually signing a co-development agreement.
“Together with Raydiant Oximetry we are proud to be at the forefront of this technology to help clinicians better manage the complexities of perinatal care,” said Larry Boyd, general manager maternal infant care GE HealthCare. “We are excited about the potential of this technology to complement our current perinatal portfolio and help us enable care that can support every pivotal moment in labor and delivery for every family and baby.”
Milestones met, with more to come
Raydiant is raising a $40 million series B round to support the product development efforts and a 200-patient pivotal study required for FDA approval.
Raydiant’s 14-person team will also continue work on a second technology, Daisy, a novel surgical device designed to quantify blood loss, treat uterine atony (a condition where the uterus fails to contract properly after childbirth) and prevent post-partum hemorrhage (PPH) after a C-section delivery. PPH after C-section claims the life of a new mother every four minutes around the world. It is currently the only device designed to help women after C-sections, rather than vaginal deliveries.
Raydiant has completed a 10-patient study of Daisy that demonstrated a 28% improvement in postpartum bleeding. The team is currently working with the FDA on an IDE for a pivotal randomized controlled trial (RCT) of 200 patients which they expect to start this summer.
With women’s healthcare finally getting the attention it’s due, Ray believes Raydiant is well-positioned. “We are excited to be working on devices that will help save the lives of patients during what should be one of the most joyous times for them and their families.”