Owlet® Dream Sock -Need more development

Smart baby monitor that tracks sleep quality

Meet the new Owlet Dream Sock from the brand that has monitored over 1 million babies.

Smart monitoring at your fingertips. The Dream Sock helps you understand your baby’s sleep and know when to assist your baby for better sleep. Within the Owlet Dream App, you can view Baby’s sleep quality indicators in the moment – including wakings, heart rate, and movement – and gain actionable insights to build better sleep habits.

Digital Sleep Coach from Owlet. Create healthy sleep habits for your baby from day one thanks to Owlet’s technology and sleep program which includes an adaptable sleep schedule built just for your baby. Our technology and expert content will arm you with the tools to help the whole family sleep better.

Owlet is no longer selling its Smart Sock vital sign monitors for babies and toddlers after the FDA informed the company that the devices had been improperly brought to market.

The Smart Sock can be worn by children ages 0 to 5 to track their sleep patterns, blood oxygen saturation and pulse rate. The device automatically transmits the collected data to a connected base station and smartphone app in real time and issues alerts if the readings leave a predetermined range.

In early October, the agency sent a warning letter to Owlet noting that because the Smart Sock measures vital signs including blood oxygen levels and heart rate and uses those readings to alert caregivers to potential cases of desaturation or bradycardia, it should be classified as a medical device and therefore requires FDA clearance before being sold.

“These products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body,” the regulator wrote.

disclaimer on Owlet’s website, meanwhile, still warns customers that “Owlet products are not medical devices.” It adds, “They do not and are not intended to diagnose, cure, treat, alleviate or prevent any disease or health condition or investigate, replace or modify anatomy or any physiological process.”