Owlet Unable to Shake Investor Suit Over Baby Sock FDA Approval

Owlet Inc. lost its bid to escape a lawsuit accusing the health-care technology company of misleading investors about whether it obtained necessary approval for its Smart Sock baby monitor.

The Food and Drug Administration repeatedly warned Owlet that the system, which monitors an infant’s heart rate and oxygen levels, was a medical device requiring regulatory approval, investors allege.

Owlet pulled its Smart Sock in 2021 after a warning letter from the FDA.

The complaint’s allegations give rise to the inference that Owlet knew the socks would likely qualify as a medical device but tried to market them as a wellness ...