BabySat (smart socks for kids)

2023: Device Coming to Market

At the end of June 2023, Owlet launched the BabySat smart baby sock, which tracks a child's heart rate and blood oxygen saturation.

Owlet's BabySat device, certified in June 2023, is designed to monitor, under the supervision of a doctor, children who health care providers believe may benefit from additional control at home. As soon as the wireless sock is put on the child's leg, BabySat captures the heart rate and oxygen saturation data and sends the information to the mobile application. The device sends warnings if the readings are outside the target range.

Owlet launches BabySat smart baby sock device

Owlet sold a similar device directly to consumers, but pulled it from sale after the FDA issued a warning letter accusing the company of selling the medical device without marketing authorization or approval.

An earlier Owlet device called Smart Sock had similar features, but the BabySat has adjusted reading levels, developers from Owlet said. For June 2023, the Smart Sock is only available outside the United States and Canada, and Owlet has no plans to sell the older device in these North American markets.

Getting 510 (k) clearance for BabySat is a step in Owlet's attempt to recover from regulatory issues, though the company continues to grapple with the fallout. The class-action lawsuit is moving through the U.S. legal system, and Owlet's financial position still reflects its recent difficulties.

With Smart Sock unavailable in key markets, Owlet's revenues fell 50% to $10.7 million in the first quarter of 2023. The company relies on devices including Dream Sock, a consumer product to track a child's sleep performance, for sales while it works to bring BabySat to market. Owlet filed a request with the FDA to add opportunistic notifications about heart rate and oxygen to Dream Sock.

Owlet has taken steps to reduce costs by halving its operating costs in the first quarter of 2023. Still, Owlet is still struggling financially. At the end of March 2023, the company had $24.8 million, Owlet management warned investors of significant doubts about its ability to continue continuous operations.^[1]

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