FDA clears “innovative” maternal and foetal monitoring device

The US FDA has granted clearance to a maternal and foetal monitoring device capable of measuring the electrical activity of the body.

The product, developed by the California-based maternal health company Bloomlife, is a prescription-based wearable device that aims to help healthcare providers measure maternal and foetal heart rate.

The device measures the electrical activity of the body and extracts maternal and foetal heart rate via cloud-based processing.

“Our pioneering consumer pregnancy tracker proved that women want access to more information during a pivotal time of her life,” said Eric Dy, co-founder and CEO of Bloomlife.

“The FDA clearance of Bloomlife MFM-Pro marks an important milestone by cementing our transition from consumer to medical markets.”

Earlier this year the WHO published its latest Trends in Maternal Mortality 2000 to 2020, which showed globally that in 2020 a woman died every two minutes due to pregnancy or childbirth complications. These trends are not limited to the developing world.

Before, during and after childbirth, women in the US are dying at a higher rate from pregnancy-related causes than in any other developed nation.

Increasing rates of high risk pregnancies demand greater clinical support, while decades long shortages of maternal health providers create barriers to care affecting urban and rural communities alike.

Bloomlife says it believes there is a role for technology to play in addressing this global maternal health crisis. The company aims to use technology to shift care from clinical settings to the home to deliver low-cost, “evidence-based” care.

“Covid revealed a significant amount of maternal care can be done outside of clinical settings. However, there remains a need to augment basic telehealth appointments with objective physiological data,” Dy explained.

“Utilisation of connected care solutions can not only increase the quality of virtual appointments, but allow us to build a more efficient, equitable and scalable means of screening and managing the health of mum and baby.”