Marani Health’s remote maternal monitoring system has received US Food and Drug Administration (FDA) clearance, with the company now eyeing commercialisation of its tool for addressing maternity care ‘deserts’ across the US by providing a homecare option for foetal monitoring.
Marani’s M•wrap is worn around the abdomen and uses embedded electrodes to capture foetal and maternal heart signals that are transmitted to the Minnesota-based company’s digital platform.
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Patients can view average heart rate results and record foetal movements via M•wrap’s companion app, while healthcare providers can remotely review full tracings through a portal.
For health systems and health plans, M•care helps facilitate prescribed maternal monitoring beyond the hospital or clinic, extending the reach of care teams while reducing the number of monitoring sessions taking place in a traditional clinical setting.
For patients, Marani’s tool potential means fewer trips to a hospital or clinic for prescribed monitoring – a factor the company highlighted should benefit those facing long travel distances, transportation barriers, or limited access to maternity care.
There are a range of remote monitoring platforms and wearable devices for pregnant and postpartum women, helping advance digital midwifery. However, research by maternity-focused nonprofit March of Dimes indicates that one in three US counties remains a maternity care desert, while 5.8 million women and 358,000 infants live in counties without full access to maternity care.
In addition, the report reveals that more than half of US counties lack a hospital providing labour and delivery services, with residents of maternity care deserts needing to travel approximately three times farther to reach care.
FDA clearance shifts Marani from being a developmental company to one that is now preparing for M•care’s commercialisation in 2027 – a factor that “fundamentally changes” where it is at as a company, Marani’s CEO, Ann Holder, stated.
“We now have a cleared product, a path to commercialisation, and a platform that can enable health systems to extend maternal monitoring beyond the hospital or clinic and into the home,” Holder, said.
With FDA clearance in hand, Holder highlighted that the company is now focused on bringing M•care to market and building partnerships that can “drive adoption at scale”.
“We see a significant commercial opportunity as health systems and health plans look for new ways to extend maternal monitoring beyond traditional care settings,” Holder continued.
Marani’s system is part of the remote monitoring market, which is growing at a CAGR of 1.9% and forecast to reach a valuation of around $25.7bn in 2035, as per GlobalData analysis. Other players in the remote maternal care monitoring space includes Owlet and Pulsenmore, with products for the continuous monitoring of a baby’s heart rate and oxygen saturation levels, and performing at-home ultrasound scans, respectively.
