Sibel Health Secures FDA Clearance for ANNE Maternal Monitoring Platform

Sibel Health has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ANNE Maternal platform, a wireless maternal-fetal monitoring system designed to enhance clinical decision-making through continuous data streaming and automated alerts.

Advancing Maternal and Fetal Monitoring

The Chicago-based company’s ANNE Maternal platform integrates flexible, epidermal wearable sensors that continuously capture and transmit key maternal vital signs, including respiratory rate, blood oxygen levels, skin temperature, and heart rate.

In addition, the system monitors fetal heart rate and uterine contractions, providing clinicians with a comprehensive view of both maternal and fetal health in real time.

The platform incorporates visual and audio alerts alongside an integrated Modified Early Obstetric Warning System (MEOWS), enabling automated identification of potential risks and prompting timely clinical intervention.

Designed for Clinical and Global Use

According to Steve Xu, CEO and co-founder of Sibel Health, the platform is engineered to meet stringent clinical standards while remaining adaptable for use in resource-constrained environments.

“What makes this platform unique is its ability to meet rigorous FDA requirements while also being deployable in low-resource settings,” Xu said, highlighting the company’s focus on combining clinical validation with global health impact.

Building on Existing Platform Capabilities

ANNE Maternal expands Sibel Health’s portfolio of wearable monitoring solutions and builds on its previously cleared ANNE One platform, which supports patient monitoring for adolescents and adults across hospital and home settings.

ANNE One integrates wearable sensors, AI-enabled analytics, and a mobile and cloud-based software platform to provide continuous patient monitoring and actionable insights.

Broader Innovation and Partnerships

Sibel Health continues to advance its wearable technology pipeline. Earlier this year, the FDA accepted the company’s letter of intent into its Clinical Outcome Assessment (COA) Qualification Program for a wearable cough monitoring solution under development.

The company has also received prior regulatory recognition for sensors targeting conditions such as atopic dermatitis and Parkinson’s disease.

Strategic partnerships are further expanding its capabilities, including a collaboration with LookDeep Health to combine wearable monitoring with real-time computer vision for patient safety in hospital and post-acute care settings.

Growth and Market Expansion

Sibel Health has demonstrated strong commercial momentum, securing significant funding and international partnerships. The company raised $30 million in a Series C round—later extended to $39 million—and has ongoing collaborations in Europe, including a long-term deployment agreement across hospitals in Denmark.

These initiatives are expected to scale the use of Sibel’s monitoring platforms across thousands of hospital beds and multiple regions over the coming years.

Strengthening Digital Health Innovation

With FDA clearance for ANNE Maternal, Sibel Health reinforces its position in the growing digital health and remote monitoring market—particularly in maternal care, where continuous monitoring and early intervention are critical to improving outcomes.

As healthcare systems increasingly adopt wearable and AI-driven technologies, platforms like ANNE Maternal are poised to play a key role in advancing patient safety and care delivery worldwide.