US-based Sense4Baby has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its smartphone-based maternal/fetal monitoring system.
The company has also obtained CE Mark approval from the European Commission for its remote, wireless maternal/fetal heart rate monitoring system to perform non-stress testing (NST) for high-risk pregnancies on a smartphone or tablet.
With the 510(k) and CE Mark approvals, the company can now commercialize its maternal/fetal monitoring system in the US and Europe. The device has been approved for monitoring the mother and fetus in the third trimester of pregnancy.
The Sense4Baby system is a non-invasive cardiotocograph using Doppler-based technology to measure fetal heart rate, maternal heart rate, and uterine contractions.
The system uses Bluetooth and smartphone technology to connect the monitor to a HIPAA-compliant, cloud-based data storage system with a web-enabled portal to make mother and baby’s heart rate tracings and mother’s biometric data available to physicians anytime, anywhere through 3G/4G and Wi-Fi networks.
Sense4Baby president and CEO Dr Jessica Grossman noted the company sees these clearances as major milestones in helping make maternal care more convenient and less disruptive for high-risk expectant moms with so much on their minds.
"Regulatory clearances of our innovative technology shows that our miniaturized, user-friendly system performs equivalently to a traditional bulky monitor, and helps us move towards our bigger vision of reimagining maternal care during pregnancy with smart, cellular devices in an mHealth world," Dr Grossman added.
Gary and Mary West Health Institute has originally developed the monitoring system technology and licensed to Sense4Baby in March 2013.