Maternal health technology company Marani Health announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its M•care System (MW-20), including the M•wrap wearable, marking a major regulatory and commercial milestone for the company.
The clearance represents a significant step in Marani's transition from product development to commercialization and enables the company to bring its proprietary maternal monitoring technology to market. Marani is preparing for commercial availability of the cleared system in 2027.
For patients, the clearance means prescribed maternal monitoring that has traditionally required a trip to a hospital or clinic can now be performed at home using M•wrap, while giving care teams remote access to fetal and maternal heart tracings.
"FDA clearance is a pivotal milestone for Marani and the culmination of years of technology and product development," said Ann Holder, CEO of Marani Health. "It fundamentally changes where we are as a company. We now have a cleared product, a path to commercialization, and a platform that can enable health systems to extend maternal monitoring beyond the hospital or clinic and into the home. This is the moment when M•care moves from an innovative technology we've been developing to a commercial solution we can begin bringing to patients, providers and health systems."
M•care is designed to bring prescribed maternal monitoring into the home. Worn around the abdomen, M•wrap uses embedded electrodes to capture fetal and maternal heart signals, which are transmitted to Marani's digital platform. Patients can view average heart rate results and record fetal movements through the M•wrap App, while healthcare providers can remotely review full tracings through the M•care Provider Portal. Combined with the platform's remote biometrics, digital assessments and communication tools, M•care gives care teams a more comprehensive way to stay connected with patients and monitor maternal and fetal health beyond traditional clinical settings.
The clearance comes as maternity care access continues to decline across significant parts of the United States. According to the March of Dimes 2026 maternity care report, one in three U.S. counties remains a maternity care desert, while 5.8 million women and 358,000 infants live in counties without full access to maternity care. More than half of U.S. counties lack a hospital providing labor and delivery services, and residents of maternity care deserts travel approximately three times farther to reach care.
