Nuvo Awarded FDA Clearance for its Remote Pregnancy Monitoring System INVU

Nuvo FDA clearance for INVU
Image: Nuvo

Nuvo, a private company that makes pregnancy monitoring wearables, announced that it has received clearance from the U.S. Food & Drug Administration 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. This FDA clearance now allows healthcare providers to 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).

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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, said Nuvo in a press release.

Nuvo INVU
Image: Nuvo

“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.”

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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.”