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.
Oz came up with the idea after his wife’s third pregnancy became high-risk, requiring multiple trips to the doctor’s office per week.
“During this time, an inaccurate CTG (cardiotography) reading nearly resulted in an unnecessary emergency C-section,” he wrote in an email. “The pregnancy eventually ended with an uncomplicated vaginal delivery, but the frequent trips to the hospital and scare of the false positive stayed with me.”
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
It took five years to develop INVU, Oz said, with the challenge being to capture a small, and moving, heartbeat in the mother’s womb.
“Doing this in a device that could be easily self-administered was even more of a challenge,” he wrote. “Nuvo had to design and build a platform that combines proprietary/unique hardware and software together with advanced signal processing and machine learning algorithms to overcome these challenges.”
Technical work aside, Oz said the company also spent time ensuring its system was complementary with physicians’ care plans.
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
This article has been updated with comments from Oren Oz.
