Technologies aim to improve fetal health outcomes through diagnostic innovation
The National Institutes of Health has announced the finalists in its competition to accelerate the development of diagnostic and monitoring technologies to improve fetal health outcomes focusing on low-resource settings. The 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 partnered to launch the RADx® Tech Fetal Monitoring Challenge in September 2023. The multi-phased competition aims to address the causes of fetal morbidity and mortality, including the estimated 2 million incidences of stillbirth that occur globally each year, with over 21,000 that occur in the United States alone. Novel and accessible technologies are needed to enable earlier and more accurate diagnosis, detection, and monitoring of fetal health status.
Teams that entered the challenge were required to have working prototypes and proof-of-concept data for their diagnostic or monitoring technologies with a reasonable likelihood of market entry within the next five years. They also needed to demonstrate that their technology has strong potential for accessible, cost-effective use and impact in low-resource settings, such as low- and middle-income countries, as well as areas of high-income countries where there is limited access to prenatal healthcare.
The competition attracted over 40 entries last fall from teams that included small start-ups, medium-sized companies, and academic investigators. This past January, 10 semifinalists each received $5,000 and were invited to demonstrate their technologies before a panel of evaluators at NIH. Of those, six teams have been awarded $75,000 each and will advance to the final phase of the competition—a technology development sprint that will culminate in an announcement of winners later this year.
Finalists will receive technical support through the RADx Tech program as they work to further mature their technologies and address and mitigate risks to commercialization. They will be competing for a share of up to $1.5 million in grand prizes.
Read more about the RADx Tech Fetal Monitoring Challenge.
The winning technologies are listed as follows in alphabetical order. Please note that the technologies have not yet been independently validated.
Bloomlife, San Francisco. Wearable patch for fetal monitoring. Fetal monitoring is recommended in high-risk pregnancies to identify early signs of fetal distress that may lead to brain damage or stillbirth. Bloomlife’s wearable patch enables fetal monitoring at a fraction of the cost of current standard-of-care. The device leverages highly sensitive sensors combined with advanced signal processing for fetal heart rate monitoring and fetal movement assessment. 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.
NextGen, University of California, San Francisco (UCSF). Deep learning model for detection of congenital heart disease. Complex congenital heart disease (CHD) requires surgery or other interventions within the first year of life. The team at UCSF has developed and demonstrated a deep learning model for early CHD detection from fetal ultrasound imaging. Prenatal CHD diagnosis will enable fetal therapy and offers better options for birth planning, timely cardiology referrals, interventional planning, and downstream therapeutic options.
Raydiant Oximetry, San Ramon, California. Lumerah: a transabdominal fetal pulse oximeter. Raydiant Oximetry has developed LumerahTM - a non-invasive, transabdominal fetal pulse oximeter that measures the fetal arterial blood oxygen saturation. This technology will improve the detection of fetal distress as a result of fetal hypoxia during labor & delivery. LumerahTM can be utilized during the 3rd trimester of pregnancy to assess the fetus during nonstress tests and biophysical profiles. LumerahTM will 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.
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.
Storx Technologies, Davis, California. Transabdominal Fetal Oximetry. Fetal well-being is critically dependent on access to oxygen through the placenta. Storx’s Transabdominal Fetal Oximetry (TFO) technology enables 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.
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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.