Owlet Archives - Medical Design Sourcing

The Dream Sock. [Image from Owlet]Owlet announced today that the FDA granted de novo clearance for its Dream Sock over-the-counter pulse oximetry solution for infants.

Lehi, Utah-based Owlet designed the system to enable caregivers to better care for babies at home through advanced digital technologies.

According to a news release, the now-cleared Dream Sock monitors and displays live health readings and provides health notifications. Readings include pulse rate and oxygen saturation level, while lights and alarms signal when readings fall outside of preset ranges.

Owlet plans to make the medical-grade features available to all existing and new Dream Sock users upon the coming launch. It expects that launch to begin by the end of this year. The device received clearance for use with healthy infants between 1-18 months and 6-30 pounds.

The company previously received FDA clearance for its BabySat prescription monitoring system. BabySat uses pulse oxim…

Owlet (NYSE: OWLT) announced today that it has submitted a 510(k) premarket notification to the FDA for a new prescription monitoring device for infants.

The Lehi, Utah–based company’s device uses pulse oximetry technology. Physicians could prescribe it to assist with in-home monitoring of babies who are patients. Parents receive alerts from the Owlet device when their child’s heart rate or oxygen saturation level (SpO2) does not fall within prescribed ranges.

“As noted in our recent earnings release, this is a major milestone for Owlet as we work toward our mission, representing several years of work, including clinical and safety studies,” CEO and co-founder Kurt Workman said in a news release.

“This device will help the most vulnerable of babies, and we are optimistic about and excited for the opportunity ahead as we develop and expand our core technologies to include medical devices.”

Responding to FDA warning letter

A team o…

Owlet

FDA clears Owlet over-the-counter pulse oximeter sock for infants

Owlet seeks FDA clearance for prescription pediatric monitor