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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.

INVU by Nuvo™ is a maternal-fetal monitor that non-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 (ECGlike) 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. lt 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 cloud-server 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 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 can only be scheduled by a health care provider.

PregSense is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR) and maternal heart rate (MHR). The PregSense acquires and displays the FHR and MHR tracings from abdominal surface electrodes that pick up the fetal heart biopotential and maternal heart biopotential signal, and from surface acoustic sensors that pick up the fetal PCG (fPCG; phonocardiogram) and the maternal PCG (mPCG; phonocardiogram) signals. PregSense 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. PregSense is intended to be used for a maximum of five minutes. The PregSense maternal-fetal monitor is intended for use in the antepartum period by healthcare professionals in health care facilities and by the patient in the patient's home, on the order of a physician. The PregSense is not intended for use in critical care situations or in laboring patients hospitalized for or suspected to have preterm labor. PregSense is not intended to be used for antepartum monitoring (e.g., non-stress testing).

PregSense™ is a non-invasive medical device that acquires and displays vital signs of the pregnant woman and of her fetus. It measures and processes signals picked up on the abdominal surface using sensors, electronic circuitry and processing software. Two types of sensors pick up the signals: electrocardiogram (ECG)-like sensors that capture bio-potential signals, and acoustic sensors. The biopotential (ECG-like) sensors capture fECG (heartrate of the fetus) and mECG signals (heartrate of the pregnant woman). The acoustic sensors measure the sounds from the pregnant woman's abdomen, (PCG -phonocardiogram and fPCG -fetal PCG). Monitoring of the fetal and maternal heart rate using PregSense is limited to a five-minute session. PregSense™ is an integrated platform that uses a signal acquisition tool to provide input to two separate software applications, one for the patient (PregSense™ ME) and one for the physician (PregSense™ MD). The sensors are incorporated in a belt (PregSense™ Belt) that is worn on the abdomen of the pregnant woman, where it acquires both biopotential and acoustic signals are processed at the cloud-server level where the inputs from the sensors are processed, merged and downloaded to the mobile devices of the pregnant woman and her health care provider. The PregSense™ ME application (for the patient) allows the pregnant woman to view the average maternal and fetal heart rate after a five minute session has been completed and PregSense™-MD application (for the health care provider) allows the health care provider to view the complete fetal and maternal heart rate data from the five minute session online and remotely via the internet. A monitoring session can only be initiated by a health care provider.

The Sense4Baby System Model B+ is indicated for conventional antepartum fetal monitoring applications in pregnancies greater than or equal to 24 weeks gestation. It may be used for antenatal monitoring (e.g., non-stress testing and/or uterine activity monitoring) in a health care setting or home. It is to be used by health care professionals and patients on the order of a physician. Before the Sense4Baby System Model B+ is prescribed for home use, the user (patient) must be instructed/trained in proper use of the equipment. Home uterine activity monitoring has not been shown to prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.

The Sense4Baby System, Model B+ (MSA) is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine contractions during antepartum (non-stress) testing. The system transmits the measured data to a gateway device, and then a HIPAA Compliant web based portal for storage and physician review.

The FETAL ASSIST is suitable for use in all conventional antepartum fetal monitoring applications. The FETAL ASSIST is specifically intended for use in the following specific areas: - antenatal monitoring in the hospital, doctors office, health clinic, home or community. - External Labour monitoring. - Waterbirth monitoring using optional waterproof transducers. - Home Uterine Activity Monitoring (HUAM) in conjunction with standard high-risk care, for the measurement of uterine activity for women with a history of preterm birth. - Domiciliary Non Stress Testing applications. The FETAL ASSIST is a prescription device.

The FETAL ASSIST is a modular product that provides a portable antepartum fetal monitor that produces fetal cardiotocographs (CTGs). CTG traces are displayed in real time on the Liquid Crystal Display (LCD) which is integral to the Host Unit and can be reviewed or downloaded to an external printer and/or central location. The Assist can be powered by a stand-alone rechargeable battery pack. Alternatively, the Assist can be powered from the AC-powered supply via a power adapter.