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TEL AVIV, Israel, Jan. 29, 2021 /PRNewswire/ — Nuvo Group, an rising chief in maternal-fetal well being, as we speak introduced new scientific knowledge for INVU™, an FDA-cleared, prescription-initiated, distant being pregnant monitoring platform, at the Society for Maternal Fetal Drugs (SMFM)’s 41st Annual Being pregnant Assembly. The info, introduced in a scientific poster, “Amplitude-modulation of maternal electrocardiography and phonocardiography as a novel methodology for wi-fi non-invasive uterine monitoring,” helps a brand new methodology for detecting maternal uterine exercise (MUA) examined by the Perelman Faculty of Drugs on the College of Pennsylvania and the College of Arkansas for Medical Sciences (UAMS).
MUA monitoring is a necessary component of being pregnant administration, nevertheless, present strategies to measure MUA— tocodynamometry (TOCO) and the intrauterine stress catheter (IUPC)—have limitations. The present widespread normal for measurement of MUA, TOCO, could give inaccurate readings based mostly on various components, resembling motion, belt positioning and physique mass index (BMI), whereas the present gold normal of care, measurement by way of an intrauterine stress catheter (IUPC), is invasive and restricted to intrapartum use. Moreover, each strategies should usually be carried out at a clinic or hospital.
“Nuvo acknowledges the urgent scientific want for dependable distant being pregnant monitoring choices,” says Amit Reches, chief expertise officer, Nuvo Group. “As such, we analyzed present strategies of measuring uterine exercise and developed an correct, non-invasive, distant various using our INVU platform.”
“Up to now, there are few choices for sufferers to remotely carry out their indicated fetal monitoring, necessitating frequent visits to the physician’s workplace and important affected person burden,” stated Nadav Schwarz, MD, scientific director of Outpatient Maternal Fetal Drugs Providers on the Hospital of the College of Pennsylvania. “This examine helps using maternal electrocardiographic and phonocardiographic alerts to detect contractions, increasing the choices for distant monitoring of maternal and fetal well being.”
To check a novel algorithm that permits non-invasive and dependable detection of MUA, Nuvo used a potential, comparative, open label, multicenter examine through which 40 laboring girls have been concurrently monitored for 30-60 minutes with IUPC and Nuvo’s INVU. Moreover, ten topics have been monitored with TOCO. MUA measurement by INVU was based mostly on the modulation of the maternal electrocardiographic and phonocardiographic alerts brought on by the altering medium of the contracting uterus. Three blinded assessors additionally marked the contractions for every time level.
The examine’s outcomes present that MUA monitoring by way of INVU is correct and dependable, even in girls with a BMI ≥30. INVU recognized over 87 % of contractions detected by the IUPC. These findings are along with the earlier validation and FDA clearance of INVU’s maternal and fetal coronary heart charge monitoring capabilities. The examine was used to assist a brand new 510(ok) submission for the machine, which is at the moment underneath assessment by the FDA.
About Nuvo Group
Nuvo Group is dedicated to serving suppliers and expectant moms by advancing being pregnant care with new expertise, instruments and practices. The INVU platform combines proprietary {hardware} for knowledge assortment, progressive cloud-based software program for computational energy and AI instruments to optimize the being pregnant care expertise on a world scale. INVU has acquired 510(ok) clearance from the U.S. FDA for maternal and fetal coronary heart charge monitoring, and has a 510(ok) pending for distant monitoring of maternal uterine exercise in america. Firm management is comprised of devoted knowledge engineers, skilled medical and enterprise professionals, software program designers and proud dad and mom who embrace a collective mission to provide each life a greater starting.
For extra data and full indications, contraindications, warnings and precautions together with directions to be used, go to: www.nuvocares.com
SOURCE Nuvo Group
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