Bloomlife, a 2019 Rosenman Innovator and award winning maternal health company, has gained FDA clearance for their first maternal and fetal monitoring device, Bloomlife MFM-Pro.
From the press release:
SAN FRANCISCO, Jan. 16, 2024 /PRNewswire/ — Bloomlife, the award winning maternal health company, has received clearance from the US Food and Drug Administration (FDA) for Bloomlife MFM-Pro, their first maternal and fetal monitoring device. This announcement comes on the heels of Bloomlife’s partnership with Perigen that aims to improve essential monitoring of high-risk pregnancies.
Bloomlife MFM-Pro is a prescription based wearable device designed to help healthcare providers measure maternal and fetal heart rate in the patient’s home or in the clinic. The device non-invasively measures electrical activity of the body and algorithmically extracts maternal and fetal heart rate via cloud based processing. The FDA clearance represents a major milestone in their journey transitioning from consumer to medical markets.
“Our pioneering consumer pregnancy tracker proved that women want access to more information during a pivotal time of her life. The FDA clearance of Bloomlife MFM-Pro marks an important milestone by cementing our transition from consumer to medical markets”, says Eric Dy PhD, Co-Founder and CEO of Bloomlife.
Earlier this year the WHO published their 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 believes there’s a role for technology to play in addressing this global maternal health crisis.