Marani Health Receives FDA Clearance for M•care System, Clearing the Path Toward Commercial Launch

Regulatory milestone positions maternal health technology company for 2027 commercial launch of its remote monitoring platform

MINNEAPOLIS, Sept. 24, 2026 /PRNewswire/ -- Maternal health technology company Marani Health today 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.

Those access challenges coincide with persistently high maternal mortality. In 2024, the Centers for Disease Control and Prevention reported 649 maternal deaths in the United States, representing a maternal mortality rate of 17.9 deaths per 100,000 live births. The rate among non-Hispanic Black women was 44.8 per 100,000 live births, more than three times the rate among non-Hispanic White women.

For health systems and health plans, M•care creates a new way to deliver prescribed maternal monitoring beyond the hospital or clinic, extending the reach of care teams while reducing the need for every monitoring session to take place in a traditional clinical setting. For patients, that can mean fewer trips to a hospital or clinic for prescribed monitoring—an especially important benefit for those facing long travel distances, transportation barriers or limited access to maternity care. By connecting patients and providers through remote maternal and fetal monitoring, M•care is designed to expand where care can be delivered while complementing routine prenatal visits and emergency care.

"With FDA clearance in hand, we are now focused on bringing M•care to market and building the partnerships that can drive adoption at scale," added Holder. "We see a significant commercial opportunity as health systems and health plans look for new ways to extend maternal monitoring beyond traditional care settings. M•care gives us a differentiated platform to meet that need and the potential to help shape how maternal care is delivered beyond the hospital and clinic."

Marani is preparing for commercial availability of the FDA-cleared M•care System in 2027, with an initial focus on partnerships with health systems, providers and health plans.

About Marani Health

Marani Health develops remote patient monitoring and digital health solutions for prenatal and postpartum care. Its M•care System combines proprietary monitoring technology, connected devices, digital assessments and communication tools to help care teams monitor maternal and fetal health outside traditional visits. Headquartered in Minneapolis, Marani Health was founded in collaboration with Mayo Clinic. Learn more at maranihealth.com.

Media and Investor Relations
E. Olmscheid
[email protected]

SOURCE Marani Health, Inc.