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TEL AVIV, Israel, April 15, 2020 /PRNewswire/ — Nuvo Group, a non-public firm centered on innovation in being pregnant care, at present introduced two optimistic publications reporting information taken from its potential, open-label, multicenter pivotal trial supporting its 510(okay) utility for the groundbreaking INVU™ system—an FDA-cleared, prescription-initiated, self-administered distant monitoring platform that provides medical grade measurements of fetal coronary heart fee (“FHR”) and maternal coronary heart fee (“MHR”) by way of a wi-fi, sensor band. Taken collectively, the research reveal INVU’s security and accuracy in acquiring FHR and MHR. The research additionally evaluated use of the INVU platform for distant monitoring of uterine exercise, which will probably be used to assist a deliberate 510(okay) submission to broaden the present performance.
“Nuvo is dedicated to creating and validating the instruments to allow extra distributed being pregnant care. As we transfer ahead as a industrial entity to carry the INVU platform to mothers and suppliers in its first FDA-cleared indication—capturing fetal coronary heart fee—we are going to proceed to advance R&D efforts towards rounding out INVU’s self-administered monitoring capabilities,” stated Oren Oz, Founder and Chief Govt Officer, Nuvo Group. “We look ahead to sharing the outcomes of our present trial exploring INVU’s skill to measure uterine exercise, which—along with INVU’s FDA-cleared indication to acquire medical-grade fetal coronary heart fee and maternal coronary heart fee—will allow us to supply a extra complete distant monitoring platform. Topic to FDA clearance, the addition of distant monitoring functionality for uterine exercise would permit a digital go to to incorporate a distant NST, a typical prenatal take a look at that’s at the moment given as soon as every week or extra in a healthcare setting throughout the remaining weeks of being pregnant.”
A paper titled, “Wi-fi, distant resolution for dwelling fetal and maternal coronary heart fee monitoring,” printed within the American Journal of Obstetrics & Gynecology MFM, assessed concurrent use of cardiotocography, the present normal of look after exterior FHR monitoring, with INVU. The first endpoint was INVU’s FHR restrict of settlement inside ± 10 beats per minute of FHR measured with cardiotocography. The research discovered that though captured by very totally different strategies, there was a extremely vital correlation between FHR measurements from INVU, a self-administered distant monitoring platform, and cardiotocography, which should be utilized by a medical skilled in a healthcare setting. No antagonistic occasions have been reported throughout the research.
In a poster titled, “A Novel Non-Invasive Methodology for Distant Uterine Exercise Monitoring Primarily based on R-wave Modulation of Maternal Electrocardiography,” which was introduced on the Society for Maternal Fetal Medication’s fortieth Annual Being pregnant Assembly, maternal uterine exercise (UA) throughout peak contractions was measured in a subset of the pivotal research individuals concurrently utilizing the INVU platform—which obtains UA measurements from the modulation of the R-wave part of the stomach maternal EKG (mEKG)—and the historically used technique, tocodynamometry (TOCO), which should be administered by a medical skilled in a healthcare setting and could also be impacted by maternal motion, habitus or sensor placement. A blinded knowledgeable assessor then manually recognized and marked contractions utilizing the INVU platform and TOCO. The outcomes of this preliminary research assist INVU as a novel technique to detect and monitor maternal uterine exercise with glorious sensitivity (94%) in comparison with TOCO.
A big multi-center comparative trial, measuring the INVU platform alongside conventional TOCO and gold normal intrauterine stress catheter monitoring strategies, not too long ago accomplished enrollment, having recruited 120 moms in the USA. Knowledge from this research is anticipated for use to assist a 510(okay) submission for INVU for remotely acquiring uterine exercise.
Nadav Schwartz, MD, Medical Director of Outpatient MFM Providers and Affiliate Professor of Obstetrics and Gynecology on the Hospital of the College of Pennsylvania, and investigator on the research said, “The present COVID-19 pandemic has accelerated the necessity for expertise options that may improve entry and decrease avoidable publicity whereas offering a excessive diploma of reliability, security, and accuracy. Our work is exploring whether or not we will tackle longstanding points involving entry to prenatal care akin to doctor shortages and rural geography, whereas supporting the affected person expertise.”
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 prime constancy information assortment, with progressive software program options powered by AI instruments to optimize the being pregnant care expertise on a worldwide scale. INVU has acquired 510(okay) clearance from the U.S. FDA for maternal and fetal coronary heart fee monitoring. INVU™ isn’t but cleared for distant monitoring of uterine exercise in the USA and is restricted to investigational use for this goal. Firm management is comprised of devoted information engineers, skilled medical and enterprise professionals, software program designers, and proud mother and father who embrace a collective mission to offer each life a greater starting.
For extra data and full indications, contraindications, warning, and precautions together with directions to be used, go to: www.nuvocares.com
SOURCE Nuvo Group
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