Maternal health company Bloomlife has announced the US Food and Drug Administration (FDA) clearance of its Bloomlife MFM-Pro device.
The Bloomlife MFM-Pro prescription-based wearable device is designed to monitor maternal and fetal heart rates, facilitating care in both home and clinical settings.
It can non-invasively measure the body’s electrical activity and uses cloud-based processing to algorithmically extract maternal and fetal heart rates.
Bloomlife co-founder and CEO Eric Dy said: “Our pioneering consumer pregnancy tracker proved that women want access to more information during a pivotal time of their life. The FDA clearance of Bloomlife MFM-Pro marks an important milestone by cementing our transition from consumer to medical markets.”
The latest approval follows Bloomlife’s partnership with Perigen to improve access to essential high-risk pregnancy monitoring.
The partnership, which was announced earlier this month, will combine remote patient monitoring and AI-driven analytics to bring cost-effective procedures to patients.
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Bloomlife said it aims to leverage technology to shift care from high-cost clinical environments to the home, aiming to provide evidence-based, cost-effective, high-quality, patient-centered care.
Dy added: “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.
“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 mom and baby.”
Bloomlife designs solutions for remote maternal health to improve the health and well-being of mothers and babies.
