The FDA had raised concerns about the device’s capability to display a live feed of a baby’s heart rate and oxygen levels, which are critical metrics requiring interpretation by healthcare professionals, particularly in vulnerable populations. The recent approval signifies the recognition of Owlet’s technology as medical-grade, according to Kurt Workman, Owlet’s CEO and co-founder. Owlet conducted rigorous accuracy comparisons with hospital monitors to demonstrate the reliability and precision of their device. With the ability to alert healthcare providers about any abnormal metrics, BabySat can aid in diagnosing and preventing potential complications.
