Sense4Baby Inc. — a developer of a remote, wireless maternal-fetal heart rate monitoring system to perform nonstress testing for high-risk pregnancies on a smartphone or tablet — received 510(k) clearance from the U.S. Food and Drug Administration and a CE mark from the European Commission to commercialize its medical device.
Women with high-risk pregnancies may require fetal monitoring up to twice per week. The Sense4Baby system is now cleared for health care practitioners in the U.S. and Europe to monitor mother and fetuses in the third trimester of pregnancy using a cellular device anywhere wireless access is found, according to the company.
A 510(k) clearance from the FDA gives Sense4Baby Inc. the ability to market its system in the United States. In Europe, obtaining the CE mark enables the company to sell its device in the 31 countries that make up the European Economic Area, the company said.
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 through 3G/4G and Wi-Fi networks, the company said.
In April, Sense4Baby announced it had received $4 million in funding from the West Health Investment Fund.
— SDBJ Staff Report