Owlet receives clearance to sell its baby monitoring tech in the EU

Dream Sock is an over the county monitor offering live health readings and notifications for infants

Owlet is a smart infant monitoring company that developed Dream Sock, a smart baby monitor to offer live health readings and health notifications for use with infants between one and 18 months.

Dream Sock received FDA clearance last year, and now it will be available in the European Union as well, as the company announced on Friday that it received a EU medical device certification, meaning that Owlet’s Dream Sock has been assessed and certified to meet safety and health requirements set out under EU medical device legislation.

Founded in 2012, Owlet's Dream Sock wraps around a baby's foot and is intended for routine, in-home surveillance of healthy infants by measuring oxygen saturation and pulse rate, as well as as sleep insights. Dream App delivers live readings directly to a mobile device and a nearby Base Station, both of which can notify the baby's caregiver.

Owlet's other product, called BabySat, is a Smart Sock which allows caregivers to monitor their baby’s health and collaborate with healthcare providers. BabySat is a pulse-oximetry device that can monitor a baby's heart rate and oxygen saturation level, alerting caregivers if it detects vital signs outside of prescribed ranges. It received FDA clearance last year.

The main difference between the two products is that BabySat is a prescription only, medical device intended for infants that a healthcare provider determines could benefit from additional monitoring at-home under the supervision of a physician, while Dream Sock is available over-the-counter and is intended for use on healthy infants.

Now that is has this certification, Owlet said plans to expand Dream Sock to more caregivers around the world, with an expected launch throughout Germany, France and the United Kingdom this spring, with other European countries to follow.

“Our mission to be there for every parent and every baby becomes even more realized with the European medical certification for Dream Sock,” Kurt Workman, co-founder and Chief Executive Officer at Owlet, said in statement.

“Parents throughout Europe will soon have access to the most innovative, consumer-friendly, medical-grade, smart baby monitoring technology so they can be more empowered to provide care from the comfort of their homes.”

This news comes only a week after Owlet announced a partnership with end-to-end telehealth vendor Wheel, in which Wheel clinicians will be able to prescribe BabySat.

In addition, Wheel will manage the BabySat virtual telehealth services platform, allowing its clinicians to provide caregivers of infants with prescriptions for BabySat via Wheel’s online portal and network of physicians. With a prescription, caregivers will then be able to order BabySat at little to no cost with insurance reimbursement, as it also integrates with durable medical equipment suppliers who accept and can bill for the product through numerous insurance providers.

(Image source: owletcare.com)