Sibel Health Receives FDA-Clearance for ANNE® Maternal, a Comprehensive and Fully Wireless Maternal-Fetal Monitoring Platform

Sibel Health today announced FDA 510(k) clearance of ANNE® Maternal, the world's first fully wireless, comprehensive maternal-fetal monitoring platform.

Designed for continuous, simultaneous monitoring of maternal and fetal health, ANNE® Maternal combines advanced wearable sensor technology with integrated clinical decision support — and represents a critical step toward making continuous maternal monitoring a universal standard of care. ANNE® Maternal is a sister product to ANNE® One monitoring platform already FDA-cleared for continuous monitoring of adolescents and adults in the home and hospital setting.

Designed for continuous, simultaneous monitoring of maternal and fetal health, ANNE® Maternal combines advanced wearable sensor technology with integrated clinical decision support — and represents a critical step toward making continuous maternal monitoring a universal standard of care. ANNE® Maternal is a sister product to ANNE® One monitoring platform already FDA-cleared for continuous monitoring of adolescents and adults in the home and hospital setting.

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