Sibel Health secures FDA clearance for wireless maternal-fetal monitoring platform
Alternative to traditional wired monitoring used in hospitals
Digital health company Sibel Health has received US FDA 510(k) regulatory clearance for its wireless maternal and fetal monitoring system, as it progresses development of less restrictive, more continuous monitoring during pregnancy and labour.
The ANNE Maternal platform is a fully wireless system designed as an alternative to traditional wired monitoring currently used. The system uses soft, flexible wearable sensors applied to the skin to continuously capture maternal vital signs - including heart rate, respiratory rate, oxygen saturation and temperature - alongside fetal heart rate and uterine activity. Data is streamed wirelessly to clinicians, with real-time monitoring and alerts.
This follows on from Sibel Health’s funding extension in October 2025 which brought its Series C round to $39 million. The company has also previously received grant funding of $17.5m from the Gates Foundation to support development of the platform for use in low- and middle-income countries.
"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, MD, CEO and Co-Founder of Sibel Health.
“That convergence - high-income market validation and global health impact in a single platform - is what we've been building toward since day one. We are deeply grateful to the Gates Foundation, whose continued investment has made this product possible, and to our global partners whose clinical expertise and dedication to global health have been indispensable. Together, we are closer than ever to making continuous maternal monitoring a universal standard of care.”
Moving beyond wired monitoring
Maternal–fetal monitoring has long relied on cardiotocography (CTG) systems, which typically require patients to remain connected to bedside machines via belts and wires. While widely used, these systems can limit mobility and are often associated with discomfort during labour.
Sibel Health’s ANNE Maternal platform aims to address those constraints by using wearable, wireless sensors to continuously capture physiological data from both mother and fetus.
By removing wires from the setup, the system is designed to allow greater freedom of movement for patients while maintaining clinical-grade monitoring - and this could have implications for both patient experience and clinical workflows.
The clearance arrives as the U.S. 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 U.S. a D+ in maternal and infant health, describing the system as "dangerously stalled."
Sibel’s system is also already being deployed in research settings across India, Pakistan, Nigeria and Rwanda, in collaboration with the University of Edinburgh and partners including Aga Khan University and the University of Rwanda.
Globally, around 700 women die each day from complications related to pregnancy and childbirth, the majority in settings without access to basic monitoring.
A growing focus on maternal health innovation
Wireless and wearable monitoring technologies have gained traction in recent years, particularly as healthcare systems look to expand remote and continuous monitoring capabilities. In maternal care, this has translated into efforts to improve how data is captured during pregnancy and labour, as well as how risks are identified earlier.
Sibel Health has previously focused on wireless biosensor platforms across neonatal and adult care. The ANNE Maternal system extends that approach into obstetrics, combining multiple monitoring functions into a single platform.
While FDA clearance is a key regulatory milestone, it does not guarantee widespread adoption - this will require hospitals to integrate wireless systems into its existing workflows, train staff and replace traditional CTG monitoring which may be deeply embedded.
However, wireless maternal monitoring has potential beyond the hospital setting, which could help to expand access in lower-resource settings.
A broader push toward access
Sibel Health’s wireless approach also sits within a wider set of efforts aimed at expanding access to maternal care - particularly in settings where traditional infrastructure and specialist capacity are limited.
Recent developments point to a growing focus not just on new technologies, but on how care is delivered. In the US, startup DeepEcho recently received FDA Breakthrough Device Designation for a simplified prenatal ultrasound system designed to reduce reliance on highly trained operators. The platform uses a “blind sweep” approach, allowing providers to capture data without needing to identify precise imaging angles, with software extracting key measurements.
Elsewhere, global health initiatives are focusing on scaling tools that already exist. A $52m programme led by Unitaid, in partnership with the Clinton Health Access Initiative and Amref Health Africa, aims to expand access to treatments for conditions such as preeclampsia and anaemia - both major drivers of maternal mortality despite well-established, low-cost interventions.
Together these efforts highlight how improving maternal health outcomes is not only about developing new technology, but making sure that technology can reach - and be effective - within the settings it is most needed.