The prescription-based Bloomlife MFM-Pro wearable is intended to assist medical professionals in taking maternal and foetal heart rates in clinics or at the patient's home
Bloomlife gets FDA clearance for Bloomlife MFM-Pro. (Credit: Bonnie Kittle on Unsplash)
Bloomlife, a women’s health company, has secured the US Food and Drug Administration’s (FDA) clearance for its maternal and foetal monitoring device, Bloomlife MFM-Pro.
The prescription-based Bloomlife MFM-Pro wearable is intended to assist medical professionals in taking maternal and foetal heart rates in clinics or at the patient’s home.
By using cloud-based processing, the device measures the body’s electrical activity non-invasively and algorithmically extracts the heart rates of the mother and foetus.
The FDA clearance follows Bloomlife’s collaboration with Perigen to enhance critical monitoring of high-risk pregnancies.
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 her life.
“The FDA clearance of Bloomlife MFM-Pro marks an important milestone by cementing our transition from consumer to medical markets.”
Bloomlife provides remote maternal health solutions to enhance the health of mothers and babies.
The maternal health company integrates connected devices with cloud-based analytics to improve access to care and offer clinicians the data to screen and manage pregnancy complications more effectively.
Previously, the firm developed a patch-based wearable device called Bloomlife Pregnancy Tracker to track and time contractions automatically.
Bloomlife plans to use the device to combine longitudinal data to address intractable challenges in the maternal health space.
The company shifted its focus on medical markets in 2020 to create a comprehensive remote maternal health platform to help doctors better screen and manage the rising incidence of pregnancy issues.
Bloomlife now aims to use technology to provide patient-centred, evidence-based, low-cost, high-quality care in the home, replacing expensive clinical settings.
Dy said: “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.”