FDA Approves New Device to Track Fetal, Maternal Health

Image credit: adimas | stock.adobe.com

The FDA has approved Bloomlife’s MFM-Pro, which is the maternal health company’s first maternal and fetal monitoring device. The prescription-based wearable device was designed for healthcare providers to measure maternal and fetal heart rate in the patient's home or clinic. According to Bloomlife, the device’s ability to apply non-invasive measurements of electrical activity and cloud-based processing marks a significant transition for the company from consumer to medical markets. Bloomlife said it hopes to shift maternal care from clinical settings to the home, with cost-effective, high-quality, and patient-centered care.¹

The approval follows Bloomlife’s announcement of a partnership with Perigen, which aims to enhance monitoring for high-risk pregnancies. The company initially gained recognition with the Bloomlife Pregnancy Tracker, a patch-based wearable that automatically tracked contractions. In 2020, Bloomlife shifted toward medical markets aimed at developing a comprehensive remote maternal health platform to address increasing rates of pregnancy complications. According to a World Health Organization study published the same year, at least one woman died every two minutes as a result of pregnancy or childbirth complication.¹

"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," said Eric Dy, PhD, co-founder and CEO of Bloomlife, in a company press release.¹

According to a study published in JAMA, maternal mortality rates in the United States doubled from 1999 to 2019 across every racial and ethnic group. Despite spending a considerably higher amount on personal healthcare than any other high-income country, the United States has maintained a high rate of maternal mortality compared to other countries. Citing the fact that most of these deaths are preventable, the authors of the article believe intervention has the capability to make a significant difference.²

“Maternal mortality persists as a source of worsening disparities in many US states and prevention efforts during this study period appear to have had a limited impact in addressing this health crisis,” the study authors wrote.²

Despite their findings, the same authors acknowledged that there were no data from the recent pandemic, suggesting that maternal related deaths have increased since the onset of COVID-19.²

"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 said in the release.¹ “Utilization 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 mom and baby."

References

1. Bloomlife Announces FDA Clearance of Bloomlife MFM-Pro. PR Newswire. January 16, 2024. Accessed January 17, 2023. https://www.prnewswire.com/news-releases/bloomlife-announces-fda-clearance-of-bloomlife-mfm-pro-302035052.html

2. Fleszar LG, Bryant AS, Johnson CO, et al. Trends in State-Level Maternal Mortality by Racial and Ethnic Group in the United States. JAMA. 2023;330(1):52–61. doi:10.1001/jama.2023.9043. Accessed January 17, 2024.