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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SOURCE Nuvo Group