Nuvo Group announced that it has received 510(k) clearance from the FDA to market INVU, a wearable device that remotely monitors fetal and maternal heart rates. Fetal and maternal heart rates are important measurements late in pregnancy, and an elevated fetal heart rate can be one of the first signals of fetal distress. Currently, obtaining these vital signs requires regular office visits and use of an Electronic Fetal Monitor. INVU allows patients and physicians to monitor these data points remotely with convenience and accuracy. The device will be prescription-only and is meant for use in the third trimester of pregnancy. The healthcare provider will schedule remote monitoring sessions, during which the patient wears the INVU sensor band to collect heart rate data. Measurements are accessible through a smartphone app and are also uploaded to a clinician dashboard for the healthcare provider. The Tel Aviv-based company touts that its remote monitoring platform is especially relevant during the current COVID-19 pandemic. Dr. Joshua Copel, chair of Nuvo’s medical advisory board and professor of obstetrics and gynecology at Yale School of Medicine, said in a statement: “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.” Source
