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Pregnant women may need to visit hospitals or clinics regularly for prescribed maternal monitoring. A new technology developed by Marani Health aims to reduce these visits by allowing healthcare providers to remotely monitor maternal and foetal health.
The maternal health technology company has received US Food and Drug Administration (FDA) 510(k) clearance for its proprietary M•care System (MW-20), including the M•wrap wearable.
Following the clearance, Marani is preparing for the commercial launch of the system, which is expected to be available next year.
“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.
“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,” she added.
How the System Works
The M•care System combines Marani’s proprietary monitoring technology, connected devices, digital assessments and communication tools to help care teams monitor maternal and foetal health outside traditional visits.
M•wrap, worn around the abdomen, uses embedded electrodes to capture foetal and maternal heart signals. The data is transmitted to Marani’s digital platform, allowing healthcare teams to access the information remotely.
Through the M•wrap App, patients can view average heart-rate results and record foetal movements. Healthcare providers can remotely review full heart tracings through the M•care Provider Portal.
Improving Access to Maternity Care
For health systems and health plans, M•care provides a way to deliver prescribed maternal monitoring beyond hospitals and clinics, extending the reach of care teams while reducing the need for every monitoring session to take place in a traditional clinical setting.
For patients, this could mean fewer trips to a hospital or clinic for prescribed monitoring, particularly for those facing long travel distances, transportation barriers or limited access to maternity care.
Marani emphasises that the system is designed to improve maternity care access while complementing routine prenatal visits and emergency care.
With FDA clearance in hand, the company is now focused on bringing M•care to market and building the partnerships that can drive adoption at scale.
Holder said, “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.
Remote Pregnancy Monitoring Linked to Fewer ER Visits
A remote patient monitoring (RPM) model powered by Marani Health’s M•care System was implemented at the Medical College of Georgia at Augusta University targeting pregnant women with multiple chronic conditions or barriers to in-person care.
The pilot model enabled participants to share health data from home with an interdisciplinary care team using connected devices, including blood pressure monitors, weight scales and glucometers. Participants also underwent mental health and social determinants of health assessments as part of the programme.
Early findings showed fewer emergency department visits and improvements in chronic disease management among patients participating in the programme.
The findings highlighted the potential of care models that extend beyond the traditional clinical setting in improving patient outcomes and healthcare system efficiency.
Beyond clinical outcomes, the model also points to potential cost savings for healthcare systems.
Headquartered in Minneapolis, Marani Health was founded in collaboration with Mayo Clinic. It develops remote patient monitoring and digital health solutions for prenatal and postpartum care.
