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
Product page: INVU