Marani Health has received FDA clearance for its M•care System, a remote maternal and fetal health monitoring platform.
The prescription system features the M•wrap abdominal wearable, which uses embedded electrodes to capture maternal and fetal heart signals via Marani’s platform. Co-founded with the Mayo Clinic, the system is expected to be commercially available 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,” said Ann Holder, Marani Health CEO.
As maternity care deserts persist, Marani aims to reduce in-office visits through remote data collection, allowing physicians to review changes in heart rates and fetal movements over time.
“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 said. “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.”
