Sibel Health has received FDA 510(k) clearance for ANNE Maternal, which the company says is the world’s first fully wireless, comprehensive maternal-fetal monitoring platform. The system uses soft, flexible wearable sensors to continuously stream maternal vital signs alongside wireless fetal heart rate monitoring and uterine contraction detection – eliminating the wired equipment that restricts laboring patients to beds.
The platform includes real-time bedside and central monitoring with automated alerts when parameters warrant evaluation, and is compatible with wireless point-of-care ultrasound.
The clearance comes as the U.S. maternal mortality rate stands at 22 deaths per 100,000 live births – the highest of any high-income nation. But the platform has a dual mandate: it meets FDA clinical standards while also being designed for deployment in resource-limited settings. The Gates Foundation has awarded Sibel Health $22.5 million in grants to advance continuous maternal monitoring across low- and middle-income countries, and ANNE Maternal is already deployed across India, Pakistan, Nigeria, and Rwanda. Globally, approximately 700 women die every day in pregnancy or childbirth, the vast majority without access to vital signs monitoring.
“What makes this platform truly unique is its dual mandate: it meets the rigorous clinical standards demanded by the FDA while also being designed for deployment in the world’s most resource-limited settings,” said CEO and co-founder Steve Xu, MD. “That convergence – high-income market validation and global health impact in a single platform – is what we’ve been building toward since day one.”
“The day of birth should be a joyful one, but it is also a time where mothers and babies can be vulnerable to devastating complications,” said Dr. Rosemary Townsend, senior lecturer and honorary consultant in obstetrics at the University of Edinburgh. “Global researchers are using these sensors in places where the need is the greatest to understand how best to detect and prevent complications in childbirth, and support women laboring to give birth to the future.”
“In our setting, the clinician-to-patient ratios are heavily constrained and early detection of obstetric complications could be life-saving at scale,” added Dr. Kavita Bhatti, professor and department chair of obstetrics and gynecology at Christian Medical College and Hospital Ludhiana.
Sibel Health was spun out of Northwestern University with early Gates Foundation support. ANNE Maternal was featured in the 2026 Gates Foundation Annual Letter as a tool toward its 2045 goal that no mother, baby, or child dies of a preventable cause.
