Remote pregnancy monitoring company Nuvo Group announced today the FDA has granted supplemental 510(k) clearance to add a new uterine activity module to its INVU system.

INVU is a physician-prescribed, wearable pregnancy monitoring system that allows women to remotely collect fetal and maternal heart rates – and now uterine activity – while sharing data in real-time with their doctor.

The FDA indicates that INVU is used by pregnant people who are in their 32nd week of gestation or later with a singleton pregnancy. The clearance specifies that the device can be used to conduct non-stress testing, a common prenatal test used to check on a baby's health.

"The Nuvo team is elated to receive supplemental FDA clearance for remote monitoring of uterine activity," Oren Oz, the founder and CEO of Nuvo Group, said in a statement.

"The ability to combine this new indication with remote monitoring of fetal and maternal heart rates allows INVU to provide expectant mothers and their healthcare providers with a comprehensive care system that captures deep data from 32 weeks in the pregnancy – marking a key milestone in our journey to reinvent and advance pregnancy care for the 21st century."

WHAT’S THE IMPACT?

The INVU pregnancy monitoring system offers an alternative to existing methods of measuring uterine activity – tocodynamometry (TOCO) and the intrauterine pressure catheter (IUPC) – that have limitations.

TOCO is a noninvasive method that measures changes in uterine tension transmitted to the abdomen, but can give inaccurate readings if there’s too much movement or incorrect positioning, or if the patient is obese, according to the American Journal of Obstetrics and Gynecology.

Previously, the only alternative was the IUPC, which gives more reliable readings, but is invasive and poses the risk of infection, according to AJOG.

In Nuvo Group’s pivotal clinical study of INVU for measuring uterine activity that compared it to TOCO and the IUPC, the device presented a positive percent agreement rate of 84.80% to the IUPC, compared to TOCO, which was in agreement with the IUPC 37.50% of the time.

"INVU's unique ability to perform non-stress tests remotely is a significant step forward for pregnancy care," said Dr. Joshua Copel, professor of obstetrics, gynecology, and reproductive science and pediatrics at Yale School of Medicine, and chair of Nuvo Group's medical advisory board, in a statement.

"As an increasing number of patients look to telemedicine for convenient care that doesn't sacrifice quality, INVU provides a reliable solution to help monitor fetal wellbeing."

THE LARGER TREND

Nuvo Group first received 510(k) clearance for INVU’s maternal and fetal heart rate measurement capabilities last March.

While Nuvo Group has the FDA’s backing, it is not the only company developing prenatal monitoring devices. In 2017, Bloomlife received $2.3 million in grants to study and build out its wearable monitoring device.

Last year, Royal Philips shared plans to release a dispensable electrode patch that monitors both the maternal heart rate and fetal heart rate, as well as uterine activity, called the Fetal and Maternal Pod and Patch.

Fitness wearables-maker Garmin is also getting in on pregnancy tracking by releasing a slew of new features, including a pregnancy time line, updates on the baby’s size and movements, symptom tracking, educational materials and a contraction-timer app for mothers entering labor.

Last summer, FitTrack released a smart scale designed for moms-to-be called Beebo. The scale is programmed with four modes – infant, pregnancy, athlete and general mode – and has 17 different health metrics that it can measure. It can also keep track of the baby’s growth.

On the whole, the femtech market is growing and is expected to continue that trajectory going forward. By 2025, experts expect the global femtech market will reach $1.15 billion, but say the growth will be fueled by a refocus on untapped areas such as menopause, geriatric care, mental health, fibroids, endometriosis and personalized holistic care.