Home Health Care Startup gets FDA clearance for device that can monitor baby’s heart rate

Startup gets FDA clearance for device that can monitor baby’s heart rate

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Physicians will be able to prescribe a wearable sensor band to help women monitor a fetus’ health in the third trimester of a pregnancy. Nuvo Group, a Tel Aviv-based medical device company, received 510(k) clearance from the Food and Drug Administration for its sensor band.

The monitoring platform, called INVU, is worn on the abdomen, where it can collect data on maternal and fetal heart rates. The FDA approved the device for women during or after their 32nd week of gestation in a pregnancy. A 149-person study was submitted as part of the approval process, with the FDA finding that the device was sufficiently accurate and easy to use.

“Meeting 510(k) requirements has been an important part of the mission to ensure that we are delivering safe and effective prenatal monitoring solutions remotely,” Nuvo Group Founder and CEO Oren Oz said in a news release. “Now more than ever, distance health solutions like INVU are needed to minimize pregnant women’s exposure to crowded offices and infectious hospitals settings.”

Heart rate monitoring currently requires going into the doctor’s office for an electronic fetal monitor (EFM). With Nuvo Group’s device, a physician can prescribe and schedule five-minute remote-monitoring sessions from the home.  During that time, the mother can get information through a mobile app, while the data is shared with her physician.

Nuvo Group was founded in 2007. The company raised $30 million in 2018 from Shareholder Value  Management. Last fall, the company launched a medical advisory board, chaired by Dr. Joshua Copel, a professor of obstetrics, gynecology and reproductive sciences at Yale School of Medicine

“Offering pregnant women new and more convenient ways to connect with OB providers can increase access to specialty care, enhance patient experience in a way that is safe, cost-effective and risk appropriate, and—importantly during the current COVID-19 pandemic–minimize unnecessary exposure,” he said in a news release.

Photo credit: Blue Planet Studio

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