Baby-Monitoring Sock Approved by FDA

Owlet, a company known for its baby monitoring devices, has received clearance from the FDA for its product BabySat, a medical-grade pulse-ox monitor designed as a wireless “sock” for newborns and babies. This approval comes after the FDA previously ordered the company to stop selling its smart sock due to concerns about the interpretation of critical data by doctors.

Owlet CEO Kurt Workman stated that the company conducted accuracy comparisons with hospital monitors to demonstrate the product’s reliability. The BabySat device, which is a prescription device, integrates medical-grade pulse oximetry technology to measure oxygen circulation in babies aged 1 to 18 months. It is expected to be available in the US by the end of the year. Pricing information has not been disclosed, but insurance options and reimbursement may be available.