Smart baby monitoring device receives FDA clearance

A smart baby monitoring device that uses pulse oximetry technology to provide medical-grade infant monitoring has received clearance from the US Food and Drug Administration (FDA).

BabySat, the first medical pulse oximetry sock for infants aims to help parents monitor their babies at home, while under the supervision of a physician.

Available through prescription, the device, developed by the US company Owlet, uses pulse oximetry technology to provide a real-time display of the baby’s heart rate and oxygen saturation level (SpO2) and alerts parents when these readings fall outside of prescribed ranges.

This would in turn enable caregivers to feel confident in providing at-home care and help reduce the strain on medical resources, the developer says.

Innovation in the baby care space matters because some of the largest issues facing caregivers and healthcare providers have yet to be solved.

There are roughly 92 million infant care visits covering a child’s first four years of life, significantly straining the availability of hospital beds and quality of care.

“Our mission is to provide caregivers with the right information at the right time to make informed decisions about their baby’s health,” said Kurt Workman, Owlet co-founder and CEO.

“Today, parents whose babies need additional monitoring are sent home with traditional solutions that can be restrictive and more cumbersome for parents.

“BabySat pushes forward the modernisation of hospital-grade technology for at-home use, and underscores our commitment to transforming baby care solutions.”

In 2021, Owlet pulled its Smart Sock from the market after the FDA issued a warning letter condemning the unregulated device’s use in alerting parents when their babies’ heart rates or blood oxygen levels left predetermined healthy ranges.

Owlet had warned customers that its monitoring system was a consumer product and was not designed to “diagnose, cure, treat, alleviate or prevent any disease or health condition or investigate, replace or modify anatomy or any physiological process,” but the FDA suggested that the alerts could still lead parents and healthcare providers to infer that a baby was experiencing desaturation or bradycardia, and so the devices had to be reviewed by the regulator.

Now, BabySat, the new version of the product, has earned the agency’s clearance.

The device will be available in the US later this year.