Sense4Baby received 510(k) clearance from the U.S. Food and Drug Administration and a CE mark from the European Commission in 2013 to commercialize its medical device in clinical settings. The acquisition by AirStrip will initially allow women to undergo non-stress testing to monitor fetal and maternal heart rate and contraction patterns using non-invasive sensors at physicians’ offices, clinics and ambulances. AirStrip’s future plans for the Sense4Baby technology include seeking FDA clearance for home-based monitoring.
“AirStrip pioneered data mobilization in women’s services ten years ago with the first FDA-cleared application that allowed doctors to monitor live data for patients in labor in the hospital setting. As a result, one in six babies born in the US is now monitored using AirStrip ONE in labor and delivery,” AirStrip CEO Alan Portela said. “Now, AirStrip is innovating again by mobilizing waveform data of pregnant patients beyond the four walls of the hospital, expanding the ability to care for patients throughout the obstetrics care continuum.”