Sense4Baby Receives 510(k) Clearance, CE Mark
December 05, 2013 -- 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 their medical device.
Women with high risk pregnancies may require fetal monitoring up to twice per week. The Sense4Baby System (watch video) is now cleared for health care 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 Sense4Baby System allows medical professionals to conduct NST’s anytime, anywhere a mother is located, moving data rather than patients through the care continuum,” states Michael Ross, MD, MPH, Department of Obstetrics and Gynecology (OB/GYN), Harbor-UCLA Medical Center. “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 Sense4Baby System is an elegantly-designed, sleek, non-invasive cardiotocograph using proven, 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[i].
“We see 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,” says Jessica Grossman, MD, president and CEO of Sense4Baby, Inc. “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.”
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.
A 510(k) clearance from the FDA gives Sense4Baby, Inc. the ability to market their system in the United States. In Europe, obtaining the CE mark enables the company to sell its device in the 31 countries that comprise the European Economic Area, indicating that the system meets the “Essential Requirements” set by the European Directive on medical devices, and proving the company’s quality system meets the stringent requirements of the ISO 13485 quality standard for medical devices, as recognized by an independent notified body.
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.
Sense4Baby’s technology was originally developed at the Gary and Mary West Health Institute and licensed to Sense4Baby Inc. in March of 2013.
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