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 foetal 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 foetal 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 honours.
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.
The RADx Tech Fetal Monitoring Challenge targeted unacceptably high stillbirth rates and poor foetal health outcomes.
Globally, about two million stillbirths occur each year, with 40 per cent occurring after the onset of labour.
Innovation in diagnostic technology development can lead to earlier and more accurate diagnosis, detection and monitoring of foetal health status and enable appropriate medical intervention.
NIBIB Director Bruce J. Tromberg, PhD, said: “The Fetal Monitoring Challenge leverages NIBIB’s RADx Tech accelerator platform and innovation funnel approach to speed innovative technologies through the development pipeline.
“Those teams that engaged with us and achieved this prize are to be congratulated for meeting the challenge to innovate for improved foetal 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 programme as they worked to mature their technologies and reduce risks that could derail commercialisation.
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 foetal pulse oximeter
LumerahTM is a non-invasive, transabdominal foetal pulse oximeter that measures the foetal arterial blood oxygen saturation.
This technology could improve the detection of foetal distress due to foetal hypoxia during labour and delivery.
It can also be utilised during the third trimester of pregnancy to assess the foetus 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 foetal ultrasound imaging.
Prenatal CHD diagnosis could enable foetal 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 foetal vessels throughout gestation.
The technology is intended to deliver insights into foetal physiology and pathophysiology and enable the early detection of foetuses 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 foetal monitoring
This wearable patch device leverages highly sensitive sensors combined with advanced signal processing for foetal heart rate monitoring and foetal movement assessment.
The device could be used to identify early signs of foetal distress that may lead to brain damage or stillbirth.
Bloomlife plans to expand use of the device to improve access to foetal 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 foetal physiology during labour and delivery.
Heart rate and pulse oximetry are extracted from waveforms that are processed and analysed by algorithms generated through a machine-learning framework.
QMIM could enable the identification of data that predict problematic foetal cardiovascular functions. QMIM’s sensor requires only a mobile phone application for interpretation.
Storx Technologies, Davis, California
Transabdominal Foetal Oximetry
This technology can enable non-invasive measurement of foetal arterial blood oxygen saturation through the maternal abdomen, thereby assisting providers in assessment of foetal wellbeing during labour 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 foetal monitoring approaches with poor specificity, and enhanced monitoring of at-risk pregnancies earlier in the gestational period.
