Pregnancy care device developer Nuvo Group said late last week it launched a trial of its PregSense maternal fetal monitoring system to compare it against cardiotocography, which is currently the standard of care.
The Israel-based company’s PregSense device is a sensor-based wearable monitoring technology designed to measure markers of fetal and maternal wellbeing from metrics including fetal movements, fetal heart rate, maternal heart rate and uterine activity through the use of surface electrodes.
The 200-patient trial is slated to be conducted across four international sites, with a primary endpoint of assessing the agreement between PregSense data collection and values measured by CTG prenatal monitoring, Nuvo Group said.
Endpoints in the the trial include fetal heart rate, maternal heart rate and uterine activity collected with both the PregSense and through CTG, the company said. The trial is expected to last up to two years.
“Pregnancy monitoring technology has changed little in the past 30 years, putting it at odds with the expectations and needs of today’s expectant parents and health professionals. Current approaches fail to provide the continuous, real-time access to information that digital natives – parents and physicians alike — have come to expect. We hope to challenge this status quo with PregSense so that we can create a new approach to meet the needs of the modern parent. We anticipate a wireless wearable system that will record both fetal and maternal parameters non-invasively and continuously. Our advancements in connected pregnancy technologies have the potential to better serve a segment of healthcare that has remained largely unchanged for decades,” Nuvo Group CEO Oren Oz said in a prepared statement.
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