Le Lézard
Classified in: Health
Subjects: PDT, WOM, FDA, DEI

Nuvo Group Receives 510(k) FDA Clearance for Remote Monitoring of Uterine Activity


TEL AVIV, Israel, June 10, 2021 /PRNewswire/ -- Nuvo Group?a private company commercializing INVU by Nuvotm, an FDA-cleared, patent-protected, prescription-initiated remote pregnancy monitoring platform?today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to add a new uterine activity module that provides capability for remote monitoring of uterine activity (UA). With this clearance, INVU can provide a reliable, passive alternative to existing methods of UA measurement. INVU uses only external sensors, allowing it to be used without any invasive component or the need for an in-hospital or in-clinic procedure.

INVU's UA module was tested extensively in a clinical study with 80 patients, in which the INVU UA was recorded simultaneously with and compared to the intrauterine pressure catheter (IUPC), the current gold standard of care.

This clearance, which supplements INVU's previous FDA clearance for remote monitoring of fetal and maternal heart rates (FHR and MHR), expands the clinical utility of the platform to enable antepartum fetal surveillance, such as non-stress tests (NSTs), to be performed non-invasively and remotely.

INVU will now enable providers to recognize uterine contractions in women who are being monitored at home by passively capturing a granular and unique set of physiological measures from both mother and baby to derive FHR/MHR/UA, the measurements needed to perform NSTs. Designed to provide mother-centric care, INVU can offer NSTs to women?even those who may be prescribed such tests multiple times a week?in the comfort of their homes, all under the guidance of a physician.

INVU is available by prescription from healthcare providers seeking to offer expectant mothers the option of virtual visits by having them wear the INVU Sensor Band for real-time readings. While mothers will have the ability to receive simplified data and insights via the paired INVU app, providers receive FHR and MHR tracings and UA measurements that can be used to optimize patient management.

"The Nuvo team is elated to receive supplemental FDA clearance for remote monitoring of uterine activity," says Oren Oz, founder and CEO of Nuvo Group. "The ability to combine this new indication with remote monitoring of fetal and maternal heart rates allows INVU to provide expectant mothers and their healthcare providers with a comprehensive care system that captures deep data from 32 weeks in the pregnancy?marking a key milestone in our journey to reinvent and advance pregnancy care for the 21st century." 

"INVU's unique ability to perform non-stress tests remotely is a significant step forward for pregnancy care," says Dr. Joshua Copel, professor of obstetrics, gynecology & reproductive science and pediatrics at Yale School of Medicine and chair of Nuvo's medical advisory board. "As an increasing number of patients look to telemedicine for convenient care that doesn't sacrifice quality, INVU provides a reliable solution to help monitor fetal well-being."

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 data collection, innovative cloud-based software for computational power and AI tools to optimize the pregnancy care experience on a global scale. INVU received a 510(k) clearance from the U.S. FDA for maternal and fetal heart rate monitoring in 2020 and a supplemental clearance for remote monitoring of uterine activity in May of 2021. 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.

For more information and complete indications, contraindications, warnings and precautions along with instructions for use, visit: www.nuvocares.com

 

SOURCE Nuvo Group


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News published on 10 june 2021 at 08:30 and distributed by: