Owlet Announces FDA 510(k) Submission for Prescription Pediatric Monitor

Rhea-AI Summary

Owlet, Inc. has submitted a 510(k) premarket notification to the FDA for a prescription-only medical device designed for in-home monitoring of infants. This device leverages pulse oximetry technology to alert parents when heart rate or oxygen saturation levels fall outside prescribed ranges. CEO Kurt Workman highlighted that this milestone represents significant effort over the years, including clinical studies. Owlet aims to expand its core technologies into medical devices, enhancing infant care and parental peace of mind.

Positive

• Submission of 510(k) premarket notification to the FDA is a significant milestone for Owlet.
• The new monitoring device leverages pulse oximetry technology, potentially enhancing safety for infants.
• The initiative reflects years of development, including thorough clinical and safety studies.

Negative

• None.

The Company filed a 510(k) premarket notification for its prescription-only medical device to be used in-home for babies under the supervision of a physician

LEHI, Utah--(BUSINESS WIRE)-- Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (“FDA”) for a new prescription monitoring device for infants. The Company’s device, which uses pulse oximetry technology, is intended to be prescribed by physicians for assisting with the in-home monitoring of babies under a physician’s care. The device provides alerts to parents when their baby’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,” said Kurt Workman, Owlet President, Chief Executive Officer and Co-Founder. “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. I’m grateful to our team who has worked tirelessly on this initiative, and we look forward to working through the FDA review process.”

About Owlet, Inc.
Owlet was founded by a team of parents in 2012. Owlet’s mission is to empower parents with the right information at the right time, to give them more peace of mind and help them find more joy in the journey of parenting. Owlet’s digital parenting platform aims to give parents real-time data and insights to help parents feel more calm and confident. Owlet believes that every parent deserves peace of mind and the opportunity to feel their well-rested best. To learn more, visit www.owletcare.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221006005370/en/

Investors

Mike Cavanaugh

Westwicke/ICR

Phone: +1.617.877.9641

mike.cavanaugh@westwicke.com

Media

Jane Putnam

Owlet, Inc.

Phone: +1.801.647.0025

jputnam@owletcare.com

Source: Owlet, Inc.

FAQ

What is Owlet's latest FDA submission regarding?

Owlet submitted a 510(k) premarket notification for a prescription monitoring device for infants.

What technology does the new Owlet device use?

The device uses pulse oximetry technology to monitor infants' heart rates and oxygen saturation levels.

When did Owlet announce their FDA submission?

Owlet announced the FDA submission in their press release dated October 6, 2022.

What is the purpose of Owlet's new device?

The device is designed for in-home monitoring of infants and provides alerts to parents regarding vital signs.

Who is the CEO of Owlet?

Kurt Workman is the CEO of Owlet.