Innovative devices could improve fetal health outcomes in low-resource settings
The National Institutes of Health has announced winners of the Rapid Acceleration of Diagnostics Technology (RADx® Tech) Fetal Monitoring Challenge, a $2 million prize competition to speed development of innovative medical technologies for fetal health diagnosis, detection and monitoring. Judging of six finalists in the technology development sprint phase of the challenge produced three top winners — a device to detect fetal stress, an AI model for early detection of congenital heart disease (CHD) and a wearable ultrasound patch to monitor fetal vascular health — plus three technologies taking runner-up honors. The multi-phase competition sought to advance accessible and cost-effective point-of-care and home-based devices that measure fetal health indicators and are implementable in low-resource settings both within the United States and internationally.
Sponsored by NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Bill & Melinda Gates Foundation, the RADx Tech Fetal Monitoring Challenge targeted unacceptably high stillbirth rates and poor fetal health outcomes. Globally, about two million stillbirths occur each year, with 40% occurring after the onset of labor. Over 21,000 stillbirths occur in the United States alone. Innovation in diagnostic technology development can lead to earlier and more accurate diagnosis, detection and monitoring of fetal health status and enable appropriate medical intervention.
“The Fetal Monitoring Challenge leverages NIBIB’s RADx Tech accelerator platform and innovation funnel approach to speed innovative technologies through the development pipeline,” said NIBIB Director Bruce J. Tromberg, Ph.D. “Those teams that engaged with us and achieved this prize are to be congratulated for meeting the challenge to innovate for improved fetal and neonatal health outcomes in this country and around the world.”
More than 40 competition entrants, including start-ups, medium-sized companies and academic investigators, sought prizes through months of performance assessment and milestone-based interim awards. Throughout the process, participants received technical support through the RADx Tech program as they worked to mature their technologies and reduce risks that could derail commercialization.
Finalists were awarded first, second and third-place prizes of $750,000, $400,000, and $200,000 respectively, while three runner-up teams win prizes of $50,000 each. When combined with previous interim prizes, the challenge will have awarded a total of $2 million.
The winning technologies are as follows:
First place — $750,000
Raydiant Oximetry, San Ramon, California
Lumerah: a transabdominal fetal pulse oximeter
LumerahTM is a non-invasive, transabdominal fetal pulse oximeter that measures the fetal arterial blood oxygen saturation. This technology could improve the detection of fetal distress due to fetal hypoxia during labor and delivery. It can also be utilized during the third trimester of pregnancy to assess the fetus during nonstress tests and biophysical profiles. The technology could also provide benefits as a research tool to address disparities in maternal healthcare delivery and the etiologies of intrauterine growth restriction, preterm labor, and stillbirth.
Second place — $400,000
NextGen Dx, University of California, San Francisco (UCSF)
Deep learning model for detection of congenital heart disease
This technology addresses complex congenital heart disease (CHD), which requires surgery or other interventions within the first year of life. The research team developed and demonstrated a deep learning model for early CHD detection from fetal ultrasound imaging. Prenatal CHD diagnosis could enable fetal therapy and provide better options for birth planning, timely cardiology referrals, interventional planning, and downstream therapeutic options.
Third place — $200,000
Softsonics, San Diego
A wearable ultrasound patch
Softsonics is developing a wearable ultrasound patch to continuously monitor hemodynamics in the placenta, umbilical cord, and fetal vessels throughout gestation. The technology is intended to deliver insights into fetal physiology and pathophysiology and enable the early detection of fetuses at risk of complications, injuries, and stillbirth.
Each of the following technology developers will receive runner-up prizes of $50,000:
Bloomlife, San Francisco
Wearable patch for fetal monitoring
This wearable patch device leverages highly sensitive sensors combined with advanced signal processing for fetal heart rate monitoring and fetal movement assessment. The device could be used to identify early signs of fetal distress that may lead to brain damage or stillbirth. Bloomlife plans to expand use of the device to improve access to fetal monitoring for all high-risk pregnancies, regardless of geographical location and socio-economic status.
Mayo Clinic, Rochester, Minnesota
Quantitative micro-miniature intrapartum monitor (QMIM)
QMIM is a miniaturized predictive device capable of real-time and minimally invasive monitoring of fetal physiology during labor and delivery. Heart rate and pulse oximetry are extracted from waveforms that are processed and analyzed by algorithms generated through a machine-learning framework. QMIM could enable the identification of data that predict problematic fetal cardiovascular functions. QMIM’s sensor requires only a mobile phone application for interpretation.
Storx Technologies, Davis, California
Transabdominal Fetal Oximetry
This technology can enable non-invasive measurement of fetal arterial blood oxygen saturation through the maternal abdomen, thereby assisting providers in assessment of fetal wellbeing during labor and delivery. TFO may potentially lead to improvement in the accuracy of detecting babies at risk of birth asphyxia, reduction of unnecessary intrapartum interventions associated with today’s fetal monitoring approaches with poor specificity, and enhanced monitoring of at-risk pregnancies earlier in the gestational period.
Please note that the technologies have not yet been independently validated.
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About the National Institute of Biomedical Imaging and Bioengineering (NIBIB): NIBIB’s mission is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating engineering and physical science with biology and medicine to advance our understanding of disease and its prevention, detection, diagnosis, and treatment. NIBIB supports emerging technology research and development within its internal laboratories and through grants, collaborations, and training. More information is available at the NIBIB website.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. For more information, visit https://www.nichd.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov.