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INVU by Nuvo™ is a maternal-fetal mon-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA). The INVU Sensor Band™ acquires the fetal heart electrocardiogram and maternal heart electrocardiogram signals from abdominal surface electrodes and the fetal phonocardiogram and the maternal phonocardiogram signals from surface acoustic sensors. The FHR, MHR and UA tracings are derived from these signals and presented. INVU by Nuvo™ is indicated for use by pregnant women who are in their 32nd week of gestation (or later), with a singleton pregnancy. The INVU by Nuvo™ maternal-fetal monitor is intended for use by healthcare professionals in health care facilities and by the patient in the patient's home, on the order of a physician. The INVU by Nuvo™ is indicated for antepartum fetal surveillance (i.e. non-stress testing). This system does not prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.

INVU by Nuvo™ is a non-invasive medical device that acquires and displays vital signs of the pregnant woman and her fetus. It measures and processes signals picked up on the abdominal surface using highly sensitive sensors, special electronic circuitry, and processing software. Two types of sensors pick up the signals: ECG-like sensors that pick-up bio-potential signals, and acoustic sensors. The bio-potential (ECG-like) sensors pick up the fECG (of the fetus), the mECG signals (of the pregnant woman) and the acoustic sensors measure the sounds from the pregnant woman's abdomen (PCG -phonocardiogram and fPCG - fetal PCG). The FHR, MHR, and UA tracings are derived from these signals and presented. INVU by Nuvo™ is an integrated platform that uses a signal acquisition tool to provide input related to fetal heart rate (FHR), maternal heart rate (MHR), to two separate software applications, one for the patient (INVU App) and one for the physician (INVU-Pro application), which also provides uterine activity (UA) tracings. Sensors are incorporated in a belt that is worn on the abdomen of the pregnant woman, where it acquires both biopotential and acoustic signals. The signals are processed at a cloudserver level. The sensors are attached to the pregnant woman's abdomen by a belt (INVU by Nuvo™ sensory band). An integrated electronic module receives, processes and transmits the measured data to algorithmic modules at cloud servers, where the inputs from the sensors are processed, merged, and sent to the INVU by Nuvo™ (patient) application to display the average FHR and average MHR after a 30 minute (minimum) monitoring session and to the INVU by Nuvo™ Pro (physician) application to display the complete FHR, MHR, and uterine activity data from a monitoring session. A monitoring session can only be scheduled by a health care provider. The purpose of this special 510(k) is to implement several minor improvements to straps, buckles and LED used in the device. There have also been several minor changes to the software.