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A Wearable Device For Around The Clock Fetal Monitoring

(Reuters)- Israeli medical experts have developed a wearable mobile monitor to keep a close watch on pregnant women and their fetuses as they go about their everyday lives.

The PregSense monitor has sensors woven into an elastic harness to provide data around the clock on the status of the fetus and the mother’s health in the later stages of pregnancy.

A Bluetooth-enabled device attached to the monitor collects and transmits data such as the mother and baby’s heart rates to a smartphone and stores it on a secure cloud-based database accessible only to expectant mothers and their physicians.

The device is the work of the Nuvo Group, led by Oren Oz. He says a smartphone app will eventually provide a visual representation of the data gathered by the wearable monitor.

“Now you can see both you and the baby, the heart and all the data. What you are going to get in the app eventually is visualization that can tell you where the hand is, you’re going to see if the baby is awake, you can hear your baby’s heartbeat anytime you want. And, obviously, everything about you as the mom, if you are relaxed, how you sleep, your activity, your heart activity, everything about your pregnancy will be put into data,” he explained as he demonstrated the device for a mother-to-be, Michal.

Oz founded the Nuvo Group with another pregnancy technological innovation, Ritmo, a strap allowing mothers to stream soothing music from a smartphone to gently stimulate the fetus.

Reducing dependency

The Israeli high-tech firm hopes the device will reassure anxious mothers like Michal, in week 32 of her pregnancy, who require monitoring without having to see her doctor.

“It connects me a lot more with the fetus. I’ll hear the fetus whenever I want and it will be easier for me. I also won’t have to be dependent on a doctor; at any given time I’ll be able to connect, to see and hear,” Michal said.

The PregSense strap is designed to collect data to help physicians detect symptoms that may lead to complications in pregnancy earlier.

“It’s the first time you have a huge amount of data of women and babies together about heart rate, kickings, position for fetus, etc., and we will be able to analyze this data to predict about events of pregnancy, like preterm labor, like preeclampsia and more, and we will be able to intervene in the right time,” said Varda Shalev, a medical informatics expert and active care primary physician. She is a private consultant to the Tel Aviv-based Nuvo Group.

The PregSense monitor does not use ultrasound like traditional doppler devices, which require pregnant women to lie still while physicians manually track the heartbeat of the fetus. The sensors use a patented algorithm to filter the signals it picks up into two heartbeat recordings.

Its developers say the passive sensors avoid the potential harm to tissue posed by ultrasonic devices and is perfectly safe for both the mother and baby during continuous monitoring.

The data collected is of high enough quality to be useful for clinicians and researchers.

“The sophistication of the technology and the sophistication of the sensors that we had designed for that is really making what used to be clinical data collection into passive, continuous, reliable home data collection,” said Prof. Nathan Intrator, a bio-signal expert and chief technology officer for Nuvo Group.

Electronic ECG

Nuvo Group’s advisory board member Professor Simcha Yagel, who also heads the division of obstetrics and gynecology at Hadassah, Hebrew University Medical Centers, said the electrocardiogram (ECG) provides the added value to the device.

“I think the new achievement of Nuvo is in the field of detection of the ECG traces of the fetus, not only the sound, not only the ultrasound, but truly an electronic ECG,” he told Reuters, during a routine ultrasound scan for a pregnant woman in hospital.

Oz said doctors would appreciate not having to use traditional heavy machinery, such as the cardiotocography (CTG) or electronic fetal monitor (EFM) machines to trace the fetal heartbeat. Instead, they could track and diagnose patients remotely, allowing quick detection and intervention.

“The immediate impact, the immediate benefit to doctors is that we are replacing the bulky CTG machines which are heavy and connected to the wall with the light weight mobility and continuous monitoring.” said Oz.

The consumer version of the product, known as Ritmo Beats, is to be launched for users by the end of 2015 and will cost around $250, Oz said. The clinical grade FDA-regulated device, to be teamed with a group of physicians to monitor the data and alert the mother of any unexpected events, has a 2016 launch target.

Oz said he is certain his invention will change pregnancy care management and “bring better care to more women at a fraction of the cost.”

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