The National Institutes of Health (NIH) has announced the winners of the Rapid Acceleration of Diagnostics Technology (RADx® Tech) for Maternal Health Challenge, an $8 million prize competition to encourage development of postpartum maternal health diagnostics for use in regions that have limited access to maternity care. The eight winning teams developed home-based and point-of-care diagnostics, wearables and other accessible technologies to improve postpartum health outcomes during the period when most maternal deaths occur—up to one year after delivery or the end of a pregnancy.
“In the United States, most pregnancy-related deaths are preventable. Equitable access to diagnostics can lead to timely interventions and potentially life-saving treatments,” said Diana W. Bianchi, M.D., director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which co-sponsored the challenge. “Through this challenge, NIH encouraged innovative, easy-to-use technologies that monitor common postpartum health problems, including hemorrhage, anemia, urinary infections and depression.”
The winning teams were selected from more than 80 initial submissions and had successfully progressed through two years of continuous performance assessment and milestone-based interim awards. During the competition, participants benefitted from support provided through the RADx Tech program, including mentoring from experts with significant industry experience, regulatory and manufacturing consultations and independent clinical evaluation. These experiences will aid the teams as they continue to develop and test their technologies to bring their products to market.
Six finalists won grand prizes of $525,000 each, and two runner-up teams won prizes of $300,000 each. When combined with previous interim prizes, the challenge awarded a total of $8 million. While the winning technologies are tailored for use in postpartum settings, the winners are at different stages of product development. Some products have been tested in pregnant and postpartum populations, some may be cleared by the Food and Drug Administration (FDA) for obstetric settings, and others are still early-stage.
Grand Prize Winners
Cardiex, Naperville, Illinois
A continuous, wearable monitor for cardiovascular health
Cardiex’s CONNEQT Pulse delivers central and brachial blood pressure readings along with critical arterial health insights, while its CONNEQT Band continuously tracks arterial health in real time during daily activities, providing data for managing cardiovascular risks during pregnancy. Both devices can integrate with health care providers through cloud-based connectivity.
Caretaker Medical, Charlottesville, Virginia
A wireless wrist monitor to evaluate cardiovascular health
Vitalstream is a wireless wrist monitor that is FDA-cleared to measure heart rate, blood pressure, respiration, cardiac output/stroke volume, left ventricular ejection time, and heart rate variability. Health care providers can monitor patients remotely, directly, or intermittently. The company aims to use the device to monitor postpartum patients for episodes of hypo- or hypertension, as well as detect the onset of hemorrhage and sepsis.
HemoSonics, Durham, North Carolina
A rapid, point-of-care diagnostic for postpartum hemorrhage
The Quantra System is an FDA-cleared, point-of-care diagnostic device designed to help manage acute bleeding in patients. Multi-center studies are underway to expand its clearance to obstetric patients, improving the management of peripartum bleeding.
Global Access Diagnostics, New Gloucester, Maine
A rapid home test for urinary tract infections
Urinary tract infections (UTIs) can be an issue for postpartum individuals, especially if they needed a catheter during or after delivery. The company has developed a rapid immunoassay to diagnose UTIs. The initial version was designed for health care providers. During the challenge, the test was adapted to look and feel like a home pregnancy test. When combined with telemedicine services and/or a call with a doctor, the test may enable treatment to begin earlier and without the need for an in-person appointment.
Sanguina, Peachtree Corners, Georgia
A smartphone app to detect anemia in pregnancy and postpartum anemia
AnemoCheck Mobile is a smartphone app that estimates hemoglobin levels based on an image of a user’s nail beds. The company proposes customizing the app by correlating hemoglobin data from routinely scheduled blood draws during pregnancy and before leaving the hospital to improve the accuracy of the app and to enable clinical decision making.
Sibel Health, Niles, Illinois
A remote monitoring system for home or point-of-care settings
The ANNE® One system is an FDA-cleared remote monitoring system that captures core vital signs and parameters relevant for postpartum monitoring. The system consists of two chest and index finger sensors that wirelessly connect to Android and iOS mobile devices for continuous or point-of-care measurements at home or in other settings.
Runners-Up
MyLÚA Health, Albany, New York
An AI-powered virtual care platform for maternal mental and social health monitoring
MyLÚA is an AI-powered mobile platform that provides support services for mental and social health risk management. The app engages mothers for inclusive data collection, provides virtual peer support groups, health education, an AI chatbot, local resource access, and telemedicine access to promote health literacy and patient-provider communication. MyLÚA aims to improve maternal mental health outcomes, especially for underserved populations facing access barriers, by extending virtual support and facilitating early risk identification.
PyrAmes, Cupertino, California
A wearable device for continuous, noninvasive blood pressure monitoring
Bosimi® is a noninvasive, wearable device that monitors adult blood pressure in real time. It uses neural networks to analyze pulse waveform data to provide continuous determination of systolic, diastolic, and mean blood pressure, and pulse rate. The device is designed to enable better control of blood pressure and timely treatment for postpartum women if adverse events, including preeclampsia and other hypertensive disorders of pregnancy, are detected.
NICHD, the National Institute of Biomedical Imaging and Bioengineering, the National Institute of Nursing Research and the NIH Office of Research on Women’s Health co-sponsored the challenge as part of NIH’s Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone (IMPROVE) Initiative. The initiative supports research to reduce preventable causes of maternal deaths and to improve health for women before, during and after delivery. IMPROVE includes a special emphasis on health disparities and populations disproportionately affected by severe pregnancy complications and maternal death, such as African American/Black women, American Indians/Alaska Natives, Asian Pacific Islanders, Hispanics/Latinas, very young women, women of advanced maternal age and people with disabilities.
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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 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 National Institute of Nursing Research (NINR): NINR leads nursing research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health equity into the future. For more information about NINR, visit https://www.ninr.nih.gov.
About the Office of Research on Women’s Health (ORWH): ORWH serves as the focal point for women’s health research at NIH. It is the first Public Health Service office dedicated specifically to promoting women’s health research within, as well as beyond, the NIH scientific community. The office also fosters the recruitment, retention, reentry, and advancement of women in biomedical careers. For more information about ORWH, visit https://orwh.od.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.
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