Ademi LLP is investigating possible securities fraud claims against Owlet (NYSE: OWLT). The investigation results from inaccurate statements Owlet may have made regarding its business operations and prospects.
The investigation focuses on whether Owlet properly disclosed its compliance with federal regulatory requirements in its marketing of its Owlet Smart Sock product. On October 4, Owlet announced that it had received a warning letter from the FDA United States Food and Drug Administration (“FDA”), asserting that Owlet’s marketing of the Smart Sock rendered the product a medical device requiring premarket approval from the FDA, which Owlet had not obtained. The Warning Letter asked Owlet to “cease commercial distribution of the Smart Sock for uses in measuring blood oxygen saturation and pulse rate where such metrics are intended to identify or diagnose desaturation and bradycardia using an alarm functionality to notify users that measurements are outside of preset values.”