Sibel Health secured FDA 510(k) clearance for ANNE Maternal, a fully wireless maternal-fetal monitoring system that extends its ANNE One platform5
ANNE Maternal is designed for labor triage and continuous maternal health monitoring, particularly in low-and-middle income countries (LMICs)4
Sibel Health received a $17.5 million grant from the Bill & Melinda Gates Foundation in April 2024 to advance the ANNE One solution for maternal health monitoring globally4
The company has already monitored more than 12,000 pregnancies in LMICs4
Sibel Health partners with the University of Edinburgh and the National Institute for Health and Care Research (NIHR) Global Health Research Unit on Global Surgery to develop solutions in collaboration with leading Indian, Pakistani, and Nigerian institutes4
The ANNE One platform is FDA-cleared and capable of monitoring all vital signs in home and hospital settings for patients 12 years and older using AI-enabled advanced wearable sensors4
The initiative aims to reduce obstetrical morbidity and mortality in resource-limited settings4
Sources:
4. https://medtechinnovator.org/sibel-health-awarded-a-major-grant-to-advance-maternal-monitoring-solution-for-low-and-middle-income-countries/
5. https://www.tipranks.com/news/private-companies/sibel-health-wins-fda-clearance-and-new-funding-for-wireless-anne-maternal-platform