Bloomlife Announces FDA Clearance of Bloomlife MFM-Pro
16 Jan 2024
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.
Since its inception Bloomlife has been at the forefront of maternal health innovation. The company first gained recognition with the Bloomlife Pregnancy Tracker, a patch-based wearable device designed to automatically track and time contractions. The consumer product won accolades throughout the mom and tech community winning multiple awards for design and innovation including the CES Innovation Award, CLIO Award, and BUMP Best of BabyTech award. The company's vision to leverage the device to aggregate unique longitudinal data to tackle massive intractable challenges in the maternal health space such as preterm birth resulted in additional recognition including Fast Company World Changing Ideas and Johnson and Johnson Innovation Award.
In 2020 the company shifted to focus on medical markets with the goal of developing a comprehensive remote maternal health platform to enable clinicians to better screen and manage the increasing rates of pregnancy complications.
"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.
"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. 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."
Bloomlife's efforts aim to use technology to shift care from high cost clinical settings to the home to deliver evidenced based, low cost, high quality, patient centered care. The latest achievements show that the company is well underway to achieve its mission to improve the health of moms and babies globally.
About Bloomlife
Bloomlife is a women's health company designing remote maternal health solutions to improve the health and well-being of moms and babies. They combine connected devices with cloud based analytics to improve access to care, empower women, and provide clinicians with information to more effectively screen and manage pregnancy complications. Bloomlife vision is to ensure every family gets a healthy start by enabling doctors and patients to address modifiable risk factors, detect abnormalities, and predict and prevent adverse events,
For more on Bloomlife, please visit: https://bloomlife.com/
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