TEL AVIV, Israel, Jan. 29, 2021 /PRNewswire/ -- Nuvo Group, an emerging leader in maternal-fetal health, today announced new clinical data for INVU™, an FDA-cleared, prescription-initiated, remote pregnancy monitoring platform, at the Society for Maternal Fetal Medicine (SMFM)'s 41st Annual Pregnancy Meeting. The data, presented in a scientific poster, "Amplitude-modulation of maternal electrocardiography and phonocardiography as a novel method for wireless non-invasive uterine monitoring," supports a new method for detecting maternal uterine activity (MUA) tested by the Perelman School of Medicine at the University of Pennsylvania and the University of Arkansas for Medical Sciences (UAMS).
MUA monitoring is an essential element of pregnancy management, however, existing methods to measure MUA— tocodynamometry (TOCO) and the intrauterine pressure catheter (IUPC)—have limitations. The current widespread standard for measurement of MUA, TOCO, may give inaccurate readings based on a number of factors, such as movement, belt positioning and body mass index (BMI), while the current gold standard of care, measurement via an intrauterine pressure catheter (IUPC), is invasive and limited to intrapartum use. Additionally, both methods must generally be performed at a clinic or hospital.
"Nuvo recognizes the pressing clinical need for reliable remote pregnancy monitoring options," says Amit Reches, chief technology officer, Nuvo Group. "As such, we analyzed existing methods of measuring uterine activity and developed an accurate, non-invasive, remote alternative utilizing our INVU platform."
"To date, there are few options for patients to remotely perform their indicated fetal monitoring, necessitating frequent visits to the doctor's office and significant patient burden," said Nadav Schwarz, MD, clinical director of Outpatient Maternal Fetal Medicine Services at the Hospital of the University of Pennsylvania. "This study supports the use of maternal electrocardiographic and phonocardiographic signals to detect contractions, expanding the options for remote monitoring of maternal and fetal health."
To test a novel algorithm that enables non-invasive and reliable detection of MUA, Nuvo used a prospective, comparative, open label, multicenter study in which 40 laboring women were simultaneously monitored for 30-60 minutes with IUPC and Nuvo's INVU. Additionally, ten subjects were monitored with TOCO. MUA measurement by INVU was based on the modulation of the maternal electrocardiographic and phonocardiographic signals caused by the changing medium of the contracting uterus. Three blinded assessors also marked the contractions for each time point.
The study's results show that MUA monitoring via INVU is accurate and reliable, even in women with a BMI ≥30. INVU identified over 87 percent of contractions detected by the IUPC. These findings are in addition to the previous validation and FDA clearance of INVU's maternal and fetal heart rate monitoring capabilities. The study was used to support a new 510(k) submission for the device, which is currently under review by the FDA.
About Nuvo Group Nuvo Group is committed to serving providers and expectant mothers by advancing pregnancy care with new technology, tools and practices. The INVU platform combines proprietary hardware for data collection, innovative cloud-based software for computational power and AI tools to optimize the pregnancy care experience on a global scale. INVU has received 510(k) clearance from the U.S. FDA for maternal and fetal heart rate monitoring, and has a 510(k) pending for remote monitoring of maternal uterine activity in the United States. Company leadership is comprised of dedicated data engineers, experienced medical and business professionals, software designers and proud parents who embrace a collective mission to give every life a better beginning.
For more information and complete indications, contraindications, warnings and precautions along with instructions for use, visit: www.nuvocares.com