Sense4Baby, the maternal and fetal monitoring product developed by West Health and then acquired by AirStrip Technologies, has received a second FDA 510(k) clearance, which will allow pregnant mothers to perform non-stress tests in their homes. The technology was previously only cleared for use by providers in clinical settings.
The Sense4Baby offering is a packaged kit that includes the wearable monitoring device and either a dedicated smartphone or tablet with pre-loaded Sense4Baby software. The company also offers providers a web-based portal that allows doctors to view or review all data entered through the mobile app as well as the monitoring data. It received its first FDA clearance in December 2013.
When AirStrip Technologies bought Sense4Baby to build its functionality into its AirStrip One interoperable mobility platform and application, the company announced that it planned to bring it to the home.