Marani Health Receives FDA Clearance for Home Monitoring System

Marani Health, a maternal health technology company, has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its M•care System, including the M•wrap wearable. This regulatory approval represents a significant milestone for the company as it prepares to bring its remote monitoring technology to market in 2027.

The M•care System is designed to enable the monitoring of maternal and fetal health from a patient's home. The M•wrap device, worn around the abdomen, captures heart signals and transmits them to Marani's digital platform. Patients can view average heart rate results and record fetal movements through an app, while healthcare providers can remotely review the tracings.

The clearance arrives amid declining access to maternity care in many parts of the United States, with areas designated as "maternity care deserts" posing significant barriers to accessing services. Persistently high maternal mortality rates, particularly among non-Hispanic Black women, underscore the need for innovative solutions.

Marani Health aims for the M•care System to improve care accessibility and efficiency. The company is now focusing on building partnerships with health systems and health plans to drive large-scale adoption. Commercial availability is slated for 2027.