The FDA has granted 510(k) clearance to Sibel Health’s ANNE Maternal, the first fully wireless platform for continuous, simultaneous maternal and fetal monitoring in labor, delivery, and the postpartum period.
•ANNE Maternal is the first FDA-cleared platform to provide fully wireless, continuous monitoring of maternal vital signs and fetal heart rate simultaneously, enabling patient mobility without sacrificing clinical oversight.
•The platform is compatible with wireless point-of-care ultrasound.
•The platform is covered by private insurance, Medicaid, and Medicare for eligible patients in the US, with broader nationwide partnerships currently being established.
The FDA has granted 510(k) clearance to Sibel Health for ANNE Maternal, the first fully wireless platform designed for continuous, simultaneous monitoring of maternal and fetal health during labor, delivery, and the postpartum period. The Chicago-based company announced the regulatory decision on April 9, 2026, describing the clearance as a critical step toward making continuous maternal monitoring a universal standard of care.1
ANNE Maternal employs soft, flexible epidermal wearable sensors that wirelessly stream continuous maternal vital signs—including heart rate, respiratory rate, blood oxygen saturation, and skin temperature—alongside wireless fetal heart rate monitoring and uterine contraction detection. The platform delivers real-time bedside and central monitoring with visual and audio alarms, and incorporates an integrated electronic Modified Early Obstetric Warning System, which provides automated alerts when clinical parameters warrant prompt evaluation.
The clearance comes as maternal mortality in the United States remains at a crisis level. The US maternal mortality rate stands at 22 deaths per 100,000 live births—the highest of any high-income nation and more than double the rate of most comparable countries. For the fourth consecutive year, the March of Dimes awarded the US a D+ in maternal and infant health, characterizing the nation’s performance as “dangerously stalled.”
Unlike conventional labor and delivery monitoring systems that restrict patients to beds with wired equipment, ANNE Maternal is fully wireless, enabling mobility and comfort without compromising clinical rigor. The platform is also compatible with wireless point-of-care ultrasound, offering a single unified interface for comprehensive perinatal assessment. It is a sister product to the ANNE One platform, which is already FDA-cleared for continuous monitoring of adolescents and adults in both home and hospital settings.
“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. That convergence—high-income market validation and global health impact in a single platform—is what we’ve been building toward since day one,” said Steve Xu, MD, CEO and co-founder of Sibel Health in a news release.1
ANNE Maternal is already in use across 4 countries—India, Pakistan, Nigeria, and Rwanda—through a research partnership with the University of Edinburgh and the NIHR Global Health Research Unit on Global Surgery. Globally, approximately 700 women die every day in pregnancy or childbirth, the vast majority in settings lacking access to vital signs monitoring.
“In our setting, the clinician-to-patient ratios are heavily constrained and early detection of obstetric complications could be life-saving at scale, said Kavita Bhatti, MD, professor and chair of Obstetrics and Gynecology at Christian Medical College and Hospital Ludhiana in Punjab, India, in the release.1
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 currently being established.
Reference
1. Sibel Health receives FDA clearance for ANNE® Maternal, a comprehensive and fully wireless maternal-fetal monitoring platform. Sibel Health. News release. April 9, 2026. Accessed April 10, 2026. https://www.prnewswire.com/news-releases/sibel-health-receives-fda-clearance-for-anne-maternal-a-comprehensive-and-fully-wireless-maternal-fetal-monitoring-platform-302737398.html
