TEL AVIV, Israel, Jan. 13, 2021 /PRNewswire/ — Nuvo Group—a non-public firm commercializing INVU by Nuvo™, an FDA-cleared, prescription-initiated, distant being pregnant monitoring platform—at present introduced that it has filed a 510(ok) discover with the U.S. Meals and Drug Administration (FDA) so as to add a brand new uterine exercise module that gives functionality for distant monitoring of maternal uterine exercise (MUA). INVU has already obtained FDA clearance for distant monitoring and measurement of fetal and maternal coronary heart charges.
By measuring MUA, INVU will allow suppliers to acknowledge uterine contractions in girls who’re being monitored at house. If cleared by the FDA for this indication, INVU will present a passive, non-invasive various to the present commonplace of look after MUA measurement, cardiotocography (TOCO), whereas giving physicians correct and full information in regards to the being pregnant. Present protocols require nonstress assessments to be performed in-office; by permitting expectant moms to observe these crucial markers remotely, INVU will meet the affected person the place she is, offering each peace of thoughts and comfort—notably for girls who could also be suggested by their doctor to carry out nonstress assessments a number of occasions every week.
INVU is accessible by prescription from a healthcare supplier, who initiates and schedules digital visits with the expectant mom. Throughout these visits, the mom wears the INVU Sensor Band for a real-time studying that permits her to entry simplified information and insights through the paired INVU app. On the similar time, the supplier receives fetal and maternal coronary heart fee tracings similar to the fetal viability checks that usually happen in prenatal visits, a utilization which has already been permitted by the FDA.
“I am pleased with the accomplishments Nuvo achieved in 2020, together with the FDA clearance of the INVU platform for distant monitoring of fetal and maternal coronary heart charges,” stated Oren Oz, founder and CEO of Nuvo Group. “We’re excited to develop our providing to incorporate distant monitoring of maternal uterine exercise, which is able to present expectant moms and their healthcare suppliers with extra complete information on maternal and fetal well being. This supplemental FDA clearance will mark a key milestone in Nuvo’s journey to reinvent and advance being pregnant look after the twenty first century.”
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 information assortment, modern cloud-based software program for computational energy and AI instruments to optimize the being pregnant care expertise on a world scale. INVU has obtained 510(ok) clearance from the U.S. FDA for maternal and fetal coronary heart fee monitoring, and as of January 13, 2021, has a 510(ok) pending for distant monitoring of maternal uterine exercise in america. Firm management is comprised of devoted information engineers, skilled medical and enterprise professionals, software program designers and proud dad and mom who embrace a collective mission to present 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
Media Inquiries:
Kristen Pessalano
INK & ROSES on behalf of Nuvo Group America
516-695-1293
[email protected]
SOURCE Nuvo Group
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