PHILADELPHIA, Nov. 16, 2019 /PRNewswire/ -- Nuvo Group, an emerging leader in maternal-fetal health, today announced new clinical data for INVU™, a pregnancy monitoring and management platform, at the American Heart Association Scientific Sessions 2019 in Philadelphia. The scientific poster, "Non-Invasive, Remote, Self-Administered Acquisition of Fetal and Maternal ECG During Pregnancy," was presented today, Saturday, November 16, 2019 at 4:30 p.m.
The open-label, multicenter, comparative study included close to 150 healthy women, aged 18-50 with a BMI less than 45, in the third trimester of pregnancy – 32 weeks or greater – and measured heart rates for both mother and fetus, simultaneously using the INVU technology and the traditionally used cardiotocography (CTG). Results show that INVU's maternal heart rate (MHR) and fetal heart rate (FHR) endpoints correlate highly with CTG, validating the non-invasive recording of the underlying maternal electrocardiogram (mECG) and fetal electrocardiogram (fECG), creating a powerful tool for future clinical and research use.
During the study, participants experienced the INVU platform by wearing a sensor band that uses passive, fixed location sensors to collect multiple sources of data from mother and fetus behind a physician-directed protocol. The system is specially designed to concurrently capture physiological measures from mother and fetus, including FHR and MHR. Data is transmitted to a cloud computing environment for processing and analytics and delivered to the healthcare provider team and expectant mother through tailored applications.
"Today's announcement marks an important advancement in fetal healthcare," says Dr. Jack Rychik, Director of the Fetal Heart Program and the Robert and Dolores Harrington Endowed Chair in Pediatric Cardiology at Children's Hospital of Philadelphia. "The pivotal study validates a unique tool which can accurately provide measures of fetal heart rate in a continuous, easy and readily accessible manner. This enhances our ability to detect and manage fetal arrhythmias, as well as reliably measure fetal heart rate variability over sustained periods of time. INVU provides for a new means of evaluating cardiovascular well-being in prenatal life and offers the opportunity for new insights and improved outcomes in a variety of fetal and maternal conditions."
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 high fidelity data collection, with innovative software solutions powered by AI tools to optimize the pregnancy care experience on a global scale. 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. Nuvo Group's initial product offering for healthcare providers has completed clinical investigation to support FDA clearance. A 510(k) submission is currently pending with the FDA, but the device remains investigational and is not yet available for sale in the United States.
For more information, visit: www.nuvocares.com
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The open-label, multicenter, comparative study included close to 150 healthy women, aged 18-50 with a BMI less than 45, in the third trimester of pregnancy – 32 weeks or greater – and measured heart rates for both mother and fetus, simultaneously using the INVU technology and the traditionally used cardiotocography (CTG). Results show that INVU's maternal heart rate (MHR) and fetal heart rate (FHR) endpoints correlate highly with CTG, validating the non-invasive recording of the underlying maternal electrocardiogram (mECG) and fetal electrocardiogram (fECG), creating a powerful tool for future clinical and research use.
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During the study, participants experienced the INVU platform by wearing a sensor band that uses passive, fixed location sensors to collect multiple sources of data from mother and fetus behind a physician-directed protocol. The system is specially designed to concurrently capture physiological measures from mother and fetus, including FHR and MHR. Data is transmitted to a cloud computing environment for processing and analytics and delivered to the healthcare provider team and expectant mother through tailored applications.
"Today's announcement marks an important advancement in fetal healthcare," says Dr. Jack Rychik, Director of the Fetal Heart Program and the Robert and Dolores Harrington Endowed Chair in Pediatric Cardiology at Children's Hospital of Philadelphia. "The pivotal study validates a unique tool which can accurately provide measures of fetal heart rate in a continuous, easy and readily accessible manner. This enhances our ability to detect and manage fetal arrhythmias, as well as reliably measure fetal heart rate variability over sustained periods of time. INVU provides for a new means of evaluating cardiovascular well-being in prenatal life and offers the opportunity for new insights and improved outcomes in a variety of fetal and maternal conditions."
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 high fidelity data collection, with innovative software solutions powered by AI tools to optimize the pregnancy care experience on a global scale. 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. Nuvo Group's initial product offering for healthcare providers has completed clinical investigation to support FDA clearance. A 510(k) submission is currently pending with the FDA, but the device remains investigational and is not yet available for sale in the United States.
For more information, visit: www.nuvocares.com
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SOURCE Nuvo Group
