May 31, 2020         
Sephora North America Evolves Its Beauty Insider Program   •   The American Legion calls for White House to protect vets 'borrower defense'   •   HealthyChildren.org Pays Tribute to Dad with Sweepstakes Giveaway   •   Gynesonics Receives FDA Clearance to Market Next Generation Sonata® System 2.1   •   FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal   •   CORRECTING and REPLACING PHOTO Aramark Opens More Than 100 Pop-Up Grocery Stores for Frontline Healthcare Workers   •   ProfNet Expert Alerts for May 29, 2020   •   Maine Virtual Academy Celebrates 2020 Graduates in a COVID Era: School Will Provide Pre-Recorded Ceremonies So Families Can Acce   •   Teamsters Statement On Murder Of George Floyd   •   PieMatrix Offers Free COVID-19 Back to Business Tool with CDC Content Hidden by Trump Administration   •   Caps and Gowns Go On at Home: iQ Academy Minnesota to Celebrate Class of 2020 with Online Commencement   •   DeVry University Answers the Call to Reskill America With Complimentary Technology Skills-Building Video Series   •   Career Partners International's Retirement Options Continues to Certify Retirement Planning Coaches   •   Aramark Opens More Than 100 Pop-Up Grocery Stores for Frontline Healthcare Workers   •   Robert Half's Lynne Smith Honored As An Influential Woman In Bay Area Business   •   CAIR Condemns Police Violence Against Protesters, Media and Bystanders Amid National Unrest   •   MemoryCare.com Names the Best Facilities for Senior Memory Care in Springfield, MO   •   Navigating Pregnancy and Postpartum in the COVID-19 Era   •   LetsGetChecked Debuts FDA EUA-Authorized At-Home Coronavirus (COVID-19) Sure-track Test   •   RGENIX Shows Clinical Activity of Novel Agent RGX-202 in Patients with KRAS Mutant Colorectal Cancer in Phase 1 Trial
Bookmark and Share

Nuvo Group Receives FDA Clearance for its Innovative INVU Remote Pregnancy Monitoring System

Nuvo Group Receives FDA Clearance for its Innovative INVU Remote Pregnancy Monitoring System

INVU is FDA cleared for self-administered, non-invasive remote patient monitoring of fetal heart rate and maternal heart rate

PR Newswire

TEL AVIV, Israel, March 30, 2020 /PRNewswire/ -- Nuvo Group, a private company with a bold ambition to reinvent pregnancy care for the 21st century, today announced that it has received clearance from the U.S. Food & Drug Administration ("FDA") to market INVU™, a prescription-initiated, protocol-driven remote monitoring platform that offers measurements of fetal and maternal heart rate via a wireless, self-administered INVU sensor band. Now, healthcare providers can offer a novel site for distributed pregnancy care—the mother's location—to remotely obtain documentation of medical-grade fetal heart rate (FHR) and maternal heart rate (MHR).

The INVU platform will be available by prescription from a healthcare provider who will initiate and schedule remote monitoring sessions.  INVU non-invasively measures and displays FHR and MHR tracings via a self-administered, wearable sensor band worn by the mother which passively collects multiple sources of physiological signals. During the reading, the mother can access personalized insights via a smartphone app, while her provider receives detailed data on maternal and fetal heart rate over time. INVU is indicated for use by pregnant women who need documentation of fetal heart rate activity, and who are in their 32nd week of gestation (or later), with a singleton pregnancy.

"Nuvo was founded to provide 21st century technology and tools that enable distributed pregnancy care. Meeting 510(k) requirements has been an important part of the mission to ensure that we are delivering safe and effective prenatal monitoring solutions remotely," said Oren Oz, Founder and Chief Executive Officer, Nuvo Group. "Now more than ever, distance health solutions like INVU are needed to minimize pregnant women's exposure to crowded offices and infectious hospitals settings."

Joshua Copel, MD, chair of Nuvo's Medical Advisory Board, and Professor, Obstetrics, Gynecology & Reproductive Sciences, and Pediatrics, Yale School of Medicine, said, "Offering pregnant women new and more convenient ways to connect with OB providers can increase access to specialty care, enhance patient experience in a way that is safe, cost-effective and risk appropriate, and—importantly during the current COVID-19 pandemic--minimize unnecessary exposure."

For complete indications, contraindications, warning, and precautions along with instructions for use, please see www.nuvocares.com.

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. INVU has received 510(k) clearance from the U.S. FDA for maternal and fetal heart rate monitoring. 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, visit: www.nuvocares.com

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/nuvo-group-receives-fda-clearance-for-its-innovative-invu-remote-pregnancy-monitoring-system-301031716.html

SOURCE Nuvo Group



Back to top
| Back to home page
Video

White House Live Stream
LIVE VIDEO EVERY SATURDAY
alsharpton Rev. Al Sharpton
9 to 11 am EST
jjackson Rev. Jesse Jackson
10 to noon CST


Video

LIVE BROADCASTS
Sounds Make the News ®
WAOK-Urban
Atlanta - WAOK-Urban
KPFA-Progressive
Berkley / San Francisco - KPFA-Progressive
WVON-Urban
Chicago - WVON-Urban
KJLH - Urban
Los Angeles - KJLH - Urban
WKDM-Mandarin Chinese
New York - WKDM-Mandarin Chinese
WADO-Spanish
New York - WADO-Spanish
WBAI - Progressive
New York - WBAI - Progressive
WOL-Urban
Washington - WOL-Urban

Listen to United Natiosns News