US-based Sense4Baby has obtained 510(k) approval from the US Food and Drug Administration (FDA) and CE Mark approval from the European Commission for its smartphone-based foetal monitoring system.
Sense4Baby System has been cleared for health care practitioners in the US and Europe for monitoring the mother and foetus in the third trimester of pregnancy using a cellular device anywhere wireless access is found.
With the 510(k) and CE Mark approvals, the company can now commercialise the maternal/foetal monitoring system in the US and Europe.
The remote, wireless maternal/foetal heart rate monitoring system works with smartphones and tablets for performing non-stress testing (NST) for high-risk pregnancies.
The non-invasive cardiotocograph uses Bluetooth and smartphone technology for connecting 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 said: "Regulatory clearances of our innovative technology shows that our miniaturised, 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 a mHealth world."
Gary and Mary West Health Institute has originally developed Sense4Baby’s technology and licensed this technology to Sense4Baby in March.
Sense4Baby System is currently being studied in several clinical trials for self-use by mothers at home, measuring how easy it is for them to apply the system, find the foetal heart rate and complete a successful test session.
The system will also be studied in a multicentre randomised controlled trial at Universitair Medisch Centrum Utrecht in the Netherlands in a population of women who are at increased risk of developing common pregnancy complications.
Image: Sense4Baby System receives 510(k) and CE Mark approvals. Photo: courtesy of Sense4Baby, Inc/PR Newswire.