FDA Approves Owlet’s Baby-Monitoring Sock after 2-Year Halt

Owlet’s Babysat, a wireless “sock” monitor for babies, has received FDA clearance after a previous order to halt sales.

The FDA initially raised concerns about the device displaying a baby’s heart rate and oxygen levels, requiring interpretation by doctors.

Owlet’s CEO stated that the approval demonstrates the device’s medical-grade technology, which has been validated through accuracy comparisons with hospital monitors. The device can alert healthcare providers if any metrics are abnormal, aiding in diagnosing and preventing complications.

The Dream Sock was previously released by Owlet without blood oxygen tracking, but a software upgrade later added a readout for the “average oxygen level. Priced at $299, it is a primary sleep tracker available without a prescription.

In contrast, Babysat, a prescription device, integrates medical-grade pulse oximetry technology and measures oxygen circulation in babies aged 1 to 18 months.

As the first FDA-approved device of its kind, Babysat fills a gap in the market for readily available medical-grade alternatives. It is precious for parents of infants with heart defects or chronic conditions, as it enables collaborative treatment planning with healthcare professionals.

Swift intervention can be taken if persistent low oxygen levels are detected, preventing life-threatening complications.

Owlet plans to launch Babysat in the US later this year, with insurance options expected to be available. However, its price has not been disclosed by the company.