Baby technology company Owlet has withdrawn wearable socks from the market next year October FDA warning letter that company fails to comply. News that first noticed Deseret News, comes less than a year after the company went public.
This sock is designed to monitor your baby’s heart rate, skin temperature, blood oxygen levels and sleep information. Owlet Smart Socks does not currently have an FDA marketing authorization or license. However, in the warning letter, the agency said the company is currently marketing the product as a “diagnostic tool,” which would mean it needs a 510 (k) statement.
In particular, the FDA said that baby socks “are devices because they are intended to be used to diagnose or cure, alleviate, treat or prevent a disease or other condition, or to affect the structure of the body or any function. Products that measure blood oxygen saturation and pulse are devices designed to detect (diagnose) desaturation and bradycardia and to provide an alarm to alert users that measurements are out of preset values.
According to the warning, the FDA has been in correspondence with Owlet since 2016 regarding the classification of socks. The FDA stated that the product is not covered by a compliance policy for low-risk products that promote healthy lifestyles.
WHY IT MATTERS
Ever since it hit At the NYSE in July through the SPAC merger, Owlet has had a rocky road in the public market. The company started trading at just under $ 10 a share.
When the FDA letter was released in October, the stock fell 31% per day. The stock never fully recovered this fall. As of today, the share price is just over $ 4.30.
Founded in 2013, Owlet received attention in 2015 as it raised $ 6 million in private equity funding and another $ 1 million in NIH grants. According to Crunchbase, the company has about $ 178 million in funding today.
In addition to wearable socks, the company has expanded its operations to include a baby monitor and a digital sleep training program.
Owlet is not the only company in baby monitor mode. For example, Nanit, an intelligent baby monitoring system, scored a goal $ 25 million in February, bringing its total increase to more than $ 75 million.