Bloomlife, a leader in maternal health technology, recently achieved a major milestone with the FDA clearance of their MFM-Pro device. This wearable, designed for monitoring both maternal and fetal heart rates, represents a significant shift for Bloomlife from a consumer-focused model to a clinical, medical market approach. Since its inception in 2015, Bloomlife has been at the forefront of healthtech innovation, initially gaining attention with its consumer-grade pregnancy tracker that monitored contractions non-invasively. In 2020, facing regulatory challenges, Bloomlife strategically pivoted towards medical-grade technology, necessitating a complete overhaul of its technology infrastructure and a shift in its business model from direct-to-consumer sales to a regulated, enterprise-focused approach.
The Bloomlife MFM-Pro, a prescription-based wearable, aids healthcare providers in measuring maternal and fetal heart rate in both home and clinical settings. It non-invasively measures the body’s electrical activity and extracts heart rates through cloud-based processing. “Our initial consumer pregnancy tracker showed that women want more information during a crucial time in their lives. The FDA clearance of Bloomlife MFM-Pro solidifies our transition from consumer to medical markets,” states Eric Dy, Ph.D., Co-Founder and CEO of Bloomlife.
Recent WHO data highlights the urgency of addressing maternal mortality, with a woman dying every two minutes in 2020 due to pregnancy or childbirth complications. This issue is not confined to developing countries; the U.S. also faces high maternal mortality rates. Bloomlife views technology as a key tool in tackling this global maternal health crisis. The MFM-Pro’s FDA clearance is thus a significant step not only for the company but also a recognition of the role the medical device industry can play in advancing maternal health.
Dy emphasizes the impact of COVID-19 in revealing the feasibility of remote maternal care, highlighting the need to supplement basic telehealth appointments with objective physiological data. Connected care solutions, he notes, can enhance the quality of virtual appointments and pave the way for a more efficient, equitable, and scalable approach to maternal health management.
The maternal health market has evolved notably since Bloomlife’s early days, with increased awareness and investment in women’s health today. This benefits innovators and of course also patients as integrating technology in healthcare solutions is slowly becoming more of a focus in women’s health as well. Bloomlife’s FDA clearance for the MFM-Pro is not just a win for the company but another landmark in the field of maternal health, showcasing the potential of healthcare technology to make significant, lasting impacts.
Earlier this month Bloomlife announced a partnership with PeriGen combining remote patient monitoring with AI-driven analytics to cost-effectively bring these procedures to patients rather than making them travel to testing facilities. This portability aims to improve access and adherence to clinically recommended testing and enable earlier identification of complications to improve birth outcomes.