The US Food and Drug Administration (FDA) has cleared Marani Health’s remote maternal monitoring system.  The company is now eyeing commercialization of its tool for addressing maternity care ‘deserts’ across the US by providing a homecare option for fetal monitoring.

Marani’s Mwrap is worn around the abdomen and uses embedded electrodes to capture fetal and maternal heart signals that are transmitted to the Minnesota-based company’s digital platform.

Healthcare professionals can remotely analyze complete tracings via a site, while patients can use Mwrap's companion app to record fetal movements and monitor average heart rate findings, reports Medical Device Network.

By extending the reach of care teams and lowering the number of monitoring sessions conducted in a conventional clinical setting, Mcare assists health systems and health plans in facilitating prescribed maternal monitoring outside of hospitals and clinics.

For patients, Marani’s tool potential implies fewer travels to a hospital or clinic for recommended monitoring - a consideration the company said should benefit people facing vast travel distances, transportation hurdles, or limited access to prenatal care.

Digital midwifery is being advanced by a variety of wearable technology and remote monitoring systems for expectant and new mothers. However, research by maternity-focused NGO March of Dimes suggests that one in three US counties remains a maternity care desert, while 5.8 million women and 358,000 infants live in counties without complete access to maternity care.

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According to the report, inhabitants of maternity care deserts must drive almost three times longer to receive care, and more than half of US counties lack a hospital that offers labor and delivery services.

According to Marani's CEO, Ann Holder, the FDA clearance "fundamentally changes" the firm's current condition, moving it from being a developing company to one that is currently getting ready for Mcare's commercialization in 2027.

“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,” Holder, said.

With FDA clearance in hand, Holder highlighted that the company is now focused on bringing Mcare 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 participants in the remote maternal care monitoring market includes Owlet and Pulsenmore, with equipment for the continuous monitoring of a baby’s heart rate and oxygen saturation levels, and doing at-home ultrasound scans, respectively.