Marani Health Receives FDA Clearance for M•care System

MINNEAPOLIS, Sept. 24, 2026 /CourierPR/ -- Marani Health, a maternal health technology company based in Minneapolis, has received FDA clearance for its M•care System, a remote monitoring platform designed to bring prescribed maternal monitoring into the home. This regulatory milestone positions the company for a 2027 commercial launch, marking a significant step in its transition from product development to commercialization.

The M•care System, which includes the M•wrap wearable, captures fetal and maternal heart signals using embedded electrodes. These signals are transmitted to Marani's digital platform, allowing patients to view average heart rate results and record fetal movements through the M•wrap App. Healthcare providers can remotely review full tracings through the M•care Provider Portal, providing a more comprehensive way to 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.

M•care is designed to address these access challenges by providing a new way to deliver prescribed maternal monitoring beyond the hospital or clinic. For patients, this means 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, Marani Health is now focused on bringing M•care to market and building the partnerships that can drive adoption at scale.

Marani Health's 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. The company 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.