Owlet Inc OWLT is trading significantly lower Monday after the company announced it received a Warning Letter from the U.S. Food and Drug Administration.
The FDA said Owlet's marketing and functionality in the U.S. renders its Smart Sock a medical device requiring premarket clearance or approval. Owlet has not obtained clearance or approval from the FDA.
Owlet said that its Smart Sock product was evaluated in third-party studies, in which it was shown to be safe. The company plans to continue working closely with the FDA to reach a resolution.
Owlet is engaged in providing a digital parenting platform that aims to give parents real-time data and insights to help parents feel more calm and confident.
OWLT Price Action: Owlet was halted for volatility during Monday's trading session.
The stock was down 23.40% at $4.20 at time of publication.
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