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Nuvo Group Submits 510(k) to Federal Drug Administration for Remote Monitoring of Maternal Uterine Activity

January 13, 2021 GMT
(PRNewsfoto/Nuvo Group)
(PRNewsfoto/Nuvo Group)

TEL AVIV, Israel, Jan. 13, 2021 /PRNewswire/ -- Nuvo Group—a private company commercializing INVU by Nuvo™, an FDA-cleared, prescription-initiated, remote pregnancy monitoring platform—today announced that it has filed a 510(k) notice with the U.S. Food and Drug Administration (FDA) to add a new uterine activity module that provides capability for remote monitoring of maternal uterine activity (MUA). INVU has already received FDA clearance for remote monitoring and measurement of fetal and maternal heart rates.

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By measuring MUA, INVU will enable providers to recognize uterine contractions in women who are being monitored at home. If cleared by the FDA for this indication, INVU will provide a passive, non-invasive alternative to the current standard of care for MUA measurement, cardiotocography (TOCO), while giving physicians accurate and complete data about the pregnancy. Current protocols require nonstress tests to be conducted in-office; by allowing expectant mothers to monitor these critical markers remotely, INVU will meet the patient where she is, providing both peace of mind and convenience—particularly for women who may be advised by their physician to perform nonstress tests multiple times a week.

INVU is available by prescription from a healthcare provider, who initiates and schedules virtual visits with the expectant mother. During these visits, the mother wears the INVU Sensor Band for a real-time reading that allows her to access simplified data and insights via the paired INVU app. At the same time, the provider receives fetal and maternal heart rate tracings comparable to the fetal viability checks that normally occur in prenatal visits, a usage which has already been approved by the FDA.

“I’m proud of the accomplishments Nuvo achieved in 2020, including the FDA clearance of the INVU platform for remote monitoring of fetal and maternal heart rates,” said Oren Oz, founder and CEO of Nuvo Group. “We are excited to expand our offering to include remote monitoring of maternal uterine activity, which will provide expectant mothers and their healthcare providers with more comprehensive data on maternal and fetal health. This supplemental FDA clearance will mark a key milestone in Nuvo’s journey to reinvent and advance pregnancy care for the 21st century.”

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 has received 510(k) clearance from the U.S. FDA for maternal and fetal heart rate monitoring, and as of January 13, 2021, has a 510(k) pending for remote monitoring of maternal uterine activity in the United States. 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.

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

Media Inquiries:
Kristen Pessalano
INK & ROSES on behalf of Nuvo Group America
516-695-1293
kristen@inkandroses.com

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SOURCE Nuvo Group