Sense4Baby Inc. developer of a remote wireless maternal/fetal heart rate monitoring system that performs non-stress testing for high-risk pregnancies on a smartphone or tablet has received 510 (k) clearance from FDA and a CE mark from the European Commission to commercialize the medical device. The device was originally developed at the Gary and Mary West health Institute and licensed to Sense4Baby Inc. in March 2013.
Women with high risk pregnancies may require fetal monitoring up to twice per week. The Sense4Baby System is cleared for both healthcare practitioners in the U.S. and Europe to monitor the mother and fetus in the third trimester of pregnancy using a cellular device anywhere wireless access is found.
The monitoring system is a non-invasive cardiotocograph using Doppler-based technology to measure the fetal heart rate, maternal heart rate, and uterine contractions. This is currently the standard of care for women at high risk for stillbirth as designated by the American College of Obstetrics and Gynecologists.
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 24/7 through 3G/4G and Wi-Fi networks.
The Sense4Baby System is being studied in several clinical research trials for self-use by mothers at home, measuring how easy it is for them to apply the system, find the fetal heart rate, and complete a successful test session.
The system is also slated for a multicenter randomized controlled trial in the Netherlands at Universitair Medisch Centrum Utrecht in a population of women who are at increased risk of developing common pregnancy complications.
For more information, go to http://sense4baby.com.