New Mobile-Enabled, Non-Invasive Fetal Monitoring System by Sense4Baby Gains FDA ClearanceDecember 23, 2013
December 23, 2013
California-based Sense4Baby released a mobile-enabled maternal and fetal monitoring system that allows healthcare providers to observe high-risk pregnancies and perform non-stress testing (NST) via smart phone or tablet during the antepartum period.
The device enables clinicians to perform these tests wherever cellular networks are found, not just in traditional settings such as offices, clinics and hospitals. “The Sense4Baby System allows medical professionals to conduct NST’s anytime, anywhere a mother is located, moving data rather than patients through the care continuum,” said Michael Ross, MD and MPH at Harbor-UCLA Medical Center’s Department of Obstetrics and Gynecology (OB/GYN). “The secure portal facilitates test interpretation by a specialist, ideal for health care in rural populations and for staying connected to vital data that can help ensure the safety of mother and baby.”
The Sense4Baby System is a sleek, non-invasive cardiotograph that uses Doppler-based technology to measure fetal and maternal heart rate, as well as uterine contractions. The Sense4Baby kit includes a smartphone or tablet with pre-loaded Sense4Baby software and the Portal, which is a web-based software that allows clinicians to review all the data entered via the mobile app as well as the monitoring data. It was granted a 510 (k) class II clearance by the U.S. Food and Drug Administration (FDA).
The system’s first commercial deployment was in the Netherlands, where Sense4Baby’s CEO Dr. Jessica Grossman says an advanced system for home healthcare is already in place. According to Grossman, Sense4Baby’s rollout strategy will begin with several beta testing sites in the United States, including user evaluation sites at academic and research centers.
Fetal care systems continue to improve over the years, giving both healthcare providers and expectant mothers access to better patient care. AIV offers accessories and repair services for fetal monitoring equipment. See AIV’s full line of accessories and services at http://www.aiv-inc.com/fetal-monitor-transducers.html.
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