FDA clears Sibel Health's ANNE Maternal wireless system. Salong Debbarma Fri, April 10, 2026 at 3:38 AM PDT * Sibel Health's ANNE Maternal platform, designed for simultaneous monitoring of maternal and foetal health, has received FDA clearance for use in clinical and home settings. Sibel Health has received 510(k) clearance from the US Food and Drug Administration (FDA) for ANNE Maternal, a wireless maternal-foetal monitoring platform. The platform is designed for simultaneous, continuous monitoring of both maternal and foetal health. Combining wearable sensor technology and clinical decision support, ANNE Maternal supports a move towards making continuous maternal monitoring a standard of care worldwide. The product is a sister platform to ANNE One, which is currently FDA-cleared for adolescent and adult monitoring in clinical and home settings. ANNE Maternal utilises soft, flexible epidermal wearable sensors that transmit continuous maternal vital signs, including respiratory and heart rate, blood oxygen saturation, and skin temperature, alongside foetal heart rate and uterine contraction data. Unlike traditional systems requiring women in labour to remain in beds with wired equipment, ANNE Maternal supports patient mobility without compromising clinical monitoring standards. The platform provides both bedside and central monitoring via real-time visual and audio alarms. An integrated electronic modified early obstetric warning system (MEOWS) offers clinicians automated alerts when readings suggest evaluation is necessary. Additionally, ANNE Maternal integrates with wireless point-of-care ultrasound, allowing a single interface for comprehensive perinatal care assessment. It is designed to deliver continuous monitoring in intrapartum and postpartum scenarios. Development was driven by a $17.5m grant from the Gates Foundation, supporting deployment in low-income and middle-income countries. Sibel Health CEO and co-founder Steve Xu 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." Sibel Health also secured an additional $5m grant to incorporate future AI-driven features into the platform. ANNE Maternal is already operational in Pakistan, Rwanda, Nigeria, and India through partnerships with the University of Edinburgh and the National Institute for Health and Care Research (NIHR) Global Health Research Unit on Global Surgery. "FDA clears Sibel Health's ANNE Maternal wireless system" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.

Sibel Health has received FDA 510(k) clearance for ANNE Maternal, the world's first fully wireless, comprehensive maternal-fetal monitoring platform. The wearable system continuously monitors maternal vital signs including heart rate, respiratory rate, blood oxygen saturation and skin temperature, alongside fetal heart rate and uterine contractions. The platform enables patient mobility during labour and incorporates an integrated Modified Early Obstetric Warning System to alert clinicians when parameters warrant evaluation. Development was supported by a $17.5 million grant from the Gates Foundation, with an additional $5 million for future AI-powered features. ANNE Maternal is already deployed across India, Pakistan, Nigeria and Rwanda. The clearance addresses a critical gap in US maternal care, where the mortality rate of 22 deaths per 100,000 live births is the highest among high-income nations.

Sibel Health and LookDeep Health have announced a strategic partnership combining continuous vital signs monitoring with real-time bedside AI for hospital patients. The collaboration integrates Sibel's FDA-cleared ANNE One wearable sensing platform with LookDeep's aimee clinical AI assistant, which uses visual, audio and physiologic data to provide contextual patient monitoring. The partnership aims to improve patient monitoring outside intensive care units, where most patients receive only intermittent checks. By combining continuous wearable vitals with real-time bedside context, the system helps clinicians detect early deterioration whilst reducing alarm fatigue and unnecessary interruptions. The integration is designed to work alongside existing hospital systems without vendor lock-in. Sibel Health's sensors comply with IEEE 11073 SDC standards, whilst LookDeep offers peer-reviewed AI technology. The partnership will initially launch with select health systems before wider availability.