Sense4Baby Receives 510(k) Clearance, CE Mark

Sense4Baby Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a CE mark from the European Commission to commercialize its maternal/fetal heart rate monitoring device.

The Sense4Baby System allows healthcare practitioners in the U.S. and Europe to monitor mothers and their fetuses in the third trimester of pregnancy using a cellular device anywhere wireless access is found.

“The Sense4Baby System allows medical professionals to conduct NST’s [non-stress test monitoring] anytime, anywhere a mother is located,” said Michael Ross, M.D., M.P.H., Department of Obstetrics and Gynecology (OB/GYN), Harbor-UCLA Medical Center. “The secure portal facilitates test interpretation by a specialist, ideal for healthcare in rural populations and for staying connected to data that can help ensure the safety of mother and baby.”

The Sense4Baby System is a non-invasive cardiotocograph using Doppler-based technology to measure fetal heart rate, maternal heart rate, and uterine contractions, currently the standard of care for women at high-risk for stillbirth, as designated by the American College of Obstetrics and Gynecologists. 

“We see these clearances as major milestones in helping make maternal care more convenient and less disruptive for high-risk expectant moms,” said Jessica Grossman, M.D., president and CEO of La Jolla, Calif.-based Sense4Baby Inc. “Regulatory clearances of our technology shows that our miniaturized system performs equivalently to a traditional bulky monitor, and helps us move towards our bigger vision of reimagining maternal care during pregnancy with cellular devices in an mHealth world.”

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.

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 also is 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.

Sense4Baby’s technology was originally developed at the Gary and Mary West Health Institute and licensed to Sense4Baby Inc. in March  2013.