FDA Clears Sibel Health's ANNE Maternal Wireless Maternal-Fetal Monitoring Platform

Sibel Health said on April 9 that the U.S. Food and Drug Administration has granted 510(k) clearance to ANNE Maternal, a wireless platform for continuous, simultaneous monitoring of a mother's vital signs and her baby's heart rate during labor, delivery and the postpartum period, according to the company's press release on PR Newswire.

The Chicago-based company called the product "the world's first fully wireless, comprehensive maternal-fetal monitoring platform." ANNE Maternal is a sister product to Sibel's ANNE One platform, which the company said is already FDA-cleared for continuous monitoring of adolescents and adults at home and in the hospital.

How the system works

According to the release, ANNE Maternal uses soft, flexible wearable sensors on the skin that wirelessly stream maternal heart rate, respiratory rate, blood oxygen saturation and skin temperature, alongside wireless fetal heart rate monitoring and uterine contraction detection. The company contrasted it with conventional systems that keep laboring patients in bed attached to wired equipment.

The platform provides real-time bedside and central monitoring with visual and audio alarms. It also includes an integrated electronic Modified Early Obstetric Warning System (MEOWS), which Sibel said gives clinicians automated signals when readings call for prompt evaluation. The company said the system is compatible with wireless point-of-care ultrasound, giving a single interface for perinatal assessment.

Contemporary OB/GYN reported that, according to the company's announcement, the platform is covered by private insurance, Medicaid and Medicare for eligible patients in the US, with broader nationwide partnerships being set up.

Gates funding and global deployment

Sibel said development of ANNE Maternal was anchored by a $17.5 million grant from the Gates Foundation, awarded in early 2024 to advance continuous maternal monitoring in low- and middle-income countries. The company, which was spun out of Northwestern University, said it is receiving an additional $5 million grant to develop future AI-powered features for low-resource settings and to reduce costs.

The system is already deployed in India, Pakistan, Nigeria and Rwanda in a research partnership with the University of Edinburgh and the NIHR Global Health Research Unit on Global Surgery, the company said.

"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 Steve Xu, chief executive and co-founder of Sibel Health.

The release cited a US maternal mortality rate of 22 deaths per 100,000 live births, which it described as the highest of any high-income nation. Indira Malladi, a senior regulatory affairs specialist at Sibel and lead author of the 510(k) submission, thanked the FDA for "their commitment to advancing innovative digital health technologies."

The company did not give the 510(k) number, pricing or a date for US hospital availability.