PRINCETON, N.J. and TEL AVIV, Israel, March 26, 2019 /PRNewswire/ --Nuvo Group today announced that the U.S. Food and Drug Administration (FDA) has received the PregSense remote monitoring application for the company's first De Novo classification. If granted clearance, the remote platform would be marketed under the name Invu by Nuvo™.
Invu is an investigational device under FDA review designed for remote pregnancy monitoring. The patented technology is designed to non-invasively measure and display fetal heart rate (FHR) and maternal heart rate (MHR), creating a digital dashboard. It is indicated for women who are in their 32nd week of gestation (or later), with a singleton pregnancy for both in-clinic and at home use.
The submission is based on clinical and scientific validation stemming from pivotal and usability trials. A pivotal study compared the investigational platform to cardiotocographs (CTG) – the most widely-used fetal monitoring system. Results from the multi-center study of 149 women showed that Nuvo's platform was able to accurately extract both fetal and maternal heart rates consistent with CTG, while offering the real-time convenience of a remote monitoring solution.
As Nuvo's first De Novo submission, this regulatory milestone paves the way for the company's vision of advancing maternal-fetal connected health by creating a connected pregnancy.
"We are pleased to have submitted our De Novo application for FDA review and look forward to working with the FDA to complete the review process," said Oren Oz, Founder and Chief Executive Officer of Nuvo Group. "Our goal is to enable a connected pregnancy, where mothers' visits are seamlessly connected across the home, workplace, doctor's office and hospitals."
About Nuvo Group Nuvo Group is committed to transforming pregnancy care for a new generation. Proprietary software solutions combined with innovative product design utilize big data analytics to optimize pregnancy healthcare on a global scale. Nuvo Group leadership is comprised of dedicated data engineers, medical professionals, software designers, and proud parents who share a collective vision to create new solutions for both patients and doctors, creating an immediate impact on maternal care worldwide. Nuvo's initial product offering for healthcare providers has completed clinical investigation to support FDA De Novo clearance but is not yet available for sale in the United States.