Nuvo Group Receives 510(ok) FDA Clearance for Distant Monitoring of Uterine Exercise

, Nuvo Group Receives 510(ok) FDA Clearance for Distant Monitoring of Uterine Exercise


INVU’s UA module was examined extensively in a scientific examine with 80 sufferers, during which the INVU UA was recorded concurrently with and in comparison with the intrauterine stress catheter (IUPC), the present gold customary of care.

This clearance, which dietary supplements INVU’s earlier FDA clearance for distant monitoring of fetal and maternal coronary heart charges (FHR and MHR), expands the scientific utility of the platform to allow antepartum fetal surveillance, equivalent to non-stress checks (NSTs), to be carried out non-invasively and remotely.

INVU will now allow suppliers to acknowledge uterine contractions in girls who’re being monitored at house by passively capturing a granular and distinctive set of physiological measures from each mom and child to derive FHR/MHR/UA, the measurements wanted to carry out NSTs. Designed to offer mother-centric care, INVU can provide NSTs to girls—even those that could also be prescribed such checks a number of occasions every week—within the consolation of their houses, all beneath the steering of a doctor.

INVU is out there by prescription from healthcare suppliers in search of to supply expectant moms the choice of digital visits by having them put on the INVU Sensor Band for real-time readings. Whereas moms can have the power to obtain simplified knowledge and insights through the paired INVU app, suppliers obtain FHR and MHR tracings and UA measurements that can be utilized to optimize affected person administration.

“The Nuvo crew is elated to obtain supplemental FDA clearance for distant monitoring of uterine exercise,” says Oren Oz, founder and CEO of Nuvo Group. “The power to mix this new indication with distant monitoring of fetal and maternal coronary heart charges permits INVU to offer expectant moms and their healthcare suppliers with a complete care system that captures deep knowledge from 32 weeks within the being pregnant—marking a key milestone in our journey to reinvent and advance being pregnant look after the twenty first century.” 

“INVU’s distinctive skill to carry out non-stress checks remotely is a big step ahead for being pregnant care,” says Dr. Joshua Copel, professor of obstetrics, gynecology & reproductive science and pediatrics at Yale Faculty of Drugs and chair of Nuvo’s medical advisory board. “As an growing variety of sufferers look to telemedicine for handy care that does not sacrifice high quality, INVU gives a dependable answer to assist monitor fetal well-being.”

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 worldwide scale. INVU acquired a 510(ok) clearance from the U.S. FDA for maternal and fetal coronary heart fee monitoring in 2020 and a supplemental clearance for distant monitoring of uterine exercise in Could of 2021. 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 present each life a greater starting.

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SOURCE Nuvo Group

, Nuvo Group Receives 510(ok) FDA Clearance for Distant Monitoring of Uterine Exercise


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