Nuvo Group Receives FDA Clearance for its Progressive INVU Distant Being pregnant Monitoring System

, Nuvo Group Receives FDA Clearance for its Progressive INVU Distant Being pregnant Monitoring System


TEL AVIV, Israel, March 30, 2020 /PRNewswire/ — Nuvo Group, a personal firm with a daring ambition to reinvent being pregnant take care of the twenty first century, at the moment introduced that it has acquired clearance from the U.S. Meals & Drug Administration (“FDA”) to market INVU™, a prescription-initiated, protocol-driven distant monitoring platform that provides measurements of fetal and maternal coronary heart fee through a wi-fi, self-administered INVU sensor band. Now, healthcare suppliers can supply a novel website for distributed being pregnant care—the mom’s location—to remotely acquire documentation of medical-grade fetal coronary heart fee (FHR) and maternal coronary heart fee (MHR).

The INVU platform can be obtainable by prescription from a healthcare supplier who will provoke and schedule distant monitoring periods.  INVU non-invasively measures and shows FHR and MHR tracings through a self-administered, wearable sensor band worn by the mom which passively collects a number of sources of physiological alerts. Through the studying, the mom can entry customized insights through a smartphone app, whereas her supplier receives detailed information on maternal and fetal coronary heart fee over time. INVU is indicated to be used by pregnant girls who want documentation of fetal coronary heart fee exercise, and who’re of their thirty second week of gestation (or later), with a singleton being pregnant.

“Nuvo was based to offer 21st century expertise and instruments that allow distributed being pregnant care. Assembly 510(okay) necessities has been an necessary a part of the mission to make sure that we’re delivering secure and efficient prenatal monitoring options remotely,” mentioned Oren Oz, Founder and Chief Govt Officer, Nuvo Group. “Now greater than ever, distance well being options like INVU are wanted to attenuate pregnant girls’s publicity to crowded places of work and infectious hospitals settings.”

Joshua Copel, MD, chair of Nuvo’s Medical Advisory Board, and Professor, Obstetrics, Gynecology & Reproductive Sciences, and Pediatrics, Yale Faculty of Medication, mentioned, “Providing pregnant girls new and extra handy methods to attach with OB suppliers can improve entry to specialty care, improve affected person expertise in a manner that’s secure, cost-effective and danger applicable, and—importantly through the present COVID-19 pandemic–minimize pointless publicity.”

For full indications, contraindications, warning, and precautions together with directions to be used, please see

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 top constancy information assortment, with revolutionary software program options powered by AI instruments to optimize the being pregnant care expertise on a worldwide scale. INVU has acquired 510(okay) clearance from the U.S. FDA for maternal and fetal coronary heart fee monitoring. Firm management is comprised of devoted information engineers, skilled medical and enterprise professionals, software program designers, and proud mother and father who embrace a collective mission to present each life a greater starting.

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SOURCE Nuvo Group

, Nuvo Group Receives FDA Clearance for its Progressive INVU Distant Being pregnant Monitoring System

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