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. .

旧金山，2024年1月16日/PRNewswire/--获奖的孕产妇保健公司Bloomlife已获得美国食品和药物管理局（FDA）的批准，推出其首款孕产妇和胎儿监测设备Bloomlife MFM Pro。此前，Bloomlife与Perigen合作，旨在改进对高危妊娠的基本监测。。

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.

Bloomlife MFM Pro是一款基于处方的可穿戴设备，旨在帮助医疗保健提供者在患者家中或诊所测量母亲和胎儿的心率。该设备无创测量身体的电活动，并通过基于云的处理算法提取母体和胎儿的心率。

The FDA clearance represents a major milestone in their journey transitioning from consumer to medical markets. .

FDA的批准标志着他们从消费者市场过渡到医疗市场的旅程中的一个重要里程碑。。

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.

自成立以来，Bloomlife一直处于孕产妇保健创新的前沿。该公司首先凭借Bloomlife Pregnancy Tracker获得认可，Bloomlife Pregnancy Tracker是一款基于补丁的可穿戴设备，旨在自动跟踪和记录宫缩时间。该消费产品在妈妈和科技界赢得了多项设计和创新奖项，包括CES创新奖、CLIO奖和BUMP Best of BabyTech奖。

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. .

该公司的愿景是利用该设备汇总独特的纵向数据，以应对孕产妇健康领域的巨大棘手挑战，如早产，这一愿景获得了更多认可，包括快速改变公司世界的想法和强生创新奖。。

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.

2020年，该公司转向专注于医疗市场，目标是开发一个全面的远程孕产妇健康平台，使临床医生能够更好地筛查和管理日益增加的妊娠并发症。

'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..

“我们开创性的消费者怀孕追踪机构证明，女性在生命的关键时期希望获得更多信息。Bloomlife联合创始人兼首席执行官埃里克·迪博士（EricDyPhD）表示，FDA批准Bloomlife MFM Pro标志着一个重要的里程碑，它巩固了我们从消费者市场向医疗市场的过渡。。

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.

今年早些时候，世卫组织公布了2000年至2020年孕产妇死亡率的最新趋势，该趋势显示，2020年，全球每两分钟就有一名妇女因怀孕或分娩并发症而死亡。这些趋势不仅限于发展中国家。在分娩之前、期间和之后，美国女性因妊娠相关原因而死亡的比例高于其他任何发达国家。高风险妊娠率的不断上升需要更多的临床支持，而数十年来孕产妇保健提供者的短缺为城市和农村社区带来了护理障碍。

Bloomlife believes there's a role for technology to play in addressing this global maternal health crisis. .

Bloomlife认为，技术在解决这场全球孕产妇健康危机方面可以发挥作用。。

'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.' .

“新型冠状病毒揭示了大量的孕产妇护理可以在临床环境之外进行。然而，仍然需要用客观的生理数据来增加基本的远程保健预约。利用联网护理解决方案不仅可以提高虚拟预约的质量，而且可以让我们建立一种更有效、公平和可扩展的筛查和管理母亲和婴儿健康的手段。”。

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..

Bloomlife的努力旨在利用技术将护理从高成本的临床环境转移到家庭，以提供以证据为基础的，低成本的，高质量的，以患者为中心的护理。最新的成就表明，该公司正在努力实现其改善全球母亲和婴儿健康的使命。。

About Bloomlife

关于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是一家女性健康公司，设计远程产妇健康解决方案，以改善母亲和婴儿的健康和福祉。他们将连接的设备与基于云的分析相结合，以改善获得护理的机会，赋予女性权力，并为临床医生提供信息，以更有效地筛查和管理妊娠并发症。

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,.

Bloomlife愿景是通过让医生和患者解决可改变的风险因素，检测异常，预测和预防不良事件，确保每个家庭都有一个健康的开始，。

For more on Bloomlife, please visit: https://bloomlife.com/

For more on Bloomlife, please visit: https://bloomlife.com/

SOURCE Bloomlife

源Bloomlife