Yes, the heart rate and oxygen level readings from the Owlet Smart Sock have been proven accurate. Owlet products are tested to medical device standards for accuracy and are clinically validated, so you can wholeheartedly trust the information we provide you. We hold ourselves to the highest standard because we want the best for parents and babies. The Smart Sock is a consumer product and is not regulated by the FDA as a medical device. It is not intended to be used to diagnose, treat, prevent, or cure any disease. The Smart Sock is designed to provide wellness information to a baby’s caregiver while the baby is sleeping on their back, in their own sleep space, and in a home setting.