Sense4Baby has received 510(k) clearance from the FDA and a CE mark from the European Commission for their medical device allowing for it to be commercialized.
Sense4Baby is a remote, wireless, maternal/fetal heart rate monitoring system used to perform non-stress testing (NST) for high-risk pregnancies via smartphones and tablets.
With Sense4Health, women with high risk pregnancies can remotely receive fetal monitoring during the third trimester of pregnancy. Michael Ross, MD, MPH, Department of Obstetrics and Gynecology, Harbor-UCA Medical Center, states “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.” He further comments that “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 system utilizes a non-invasive cardiotocograph with proven Doppler-based technology to measure fetal heart rate, maternal heart rate, and uterine contractions. The monitor uses Bluetooth and smartphone technology to connect to a HIPAA-compliant cloud based data storage system. Physicians use a web-portal to view mother and baby’s heart rate tracings and mother’s biometric data at any place and time where internet is available.
Sense4Baby is being studied in clinical research trials for self-use by mothers at home to find out how easy it is for mothers to apply the system in order to complete a successful test session. There are also plans for multicenter randomized tests in the Netherlands at Universitair Medisch Centrum Utrecht on a population of women with increased risk of developing common pregnancy complications.