Owlet’s system enables parents or guardians to monitor a baby’s blood oxygen level and pulse at home. Image credit: Shutterstock/FamVeld.

Caregivers can now monitor a baby’s pulse rate and oxygen at home after the US Food and Drug Administration (FDA) cleared Owlet’s BabySat device.

The system uses the company’s wire-free sock design to house pulse oximetry technology that can measure the baby’s heart rate and oxygen saturation levels. If any parameters exceed prescribed ranges, a parent or guardian is alerted via an app.

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The system is designed to be prescribed by a physician who thinks a baby would benefit from further monitoring at home.

Shares in Owlet opened 16% higher compared to the pre-announcement market close (16 June).

The FDA had previously issued the US-based baby monitoring company Owlet with a warning after the agency concluded the manufacturer had been selling the smart sock without marketing clearance or approval.

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The company pulled the product in response, but the system is now back on the prescription shelves after the FDA cleared it for use as a medical device.

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In a market projection by GlobalData, the pulse oximeter market is forecast to reach nearly $2bn by 2030. Whilst handheld pulse oximeters dominate the market share, innovative monitoring solutions that target wearable tech are also expected to drive markets.

Owlet CEO and co-founder Kurt Workman said: “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.”