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Owlet launches two FDA-cleared infant monitoring devices

Owlet has launched two medical devices, Dream Sock and BabySat, designed to provide caregivers with real-time health insights for infants.

The two new at-home infant monitors have recently received approval from the FDA.

The Dream Sock and BabySat devices aim to alleviate stress on parents by accurately tracking and displaying vital signs, alerting them to take action when necessary.

Dream Sock has been available without a prescription since its De Novo clearance by the FDA in November 2023.

Claimed to be the first and only of its kind, the device will monitor and show the baby’s live health readings, including pulse rate and oxygen saturation level.

The readings will be provided to caregivers through the Owlet Dream App.

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Owlet paediatric cardiologist and senior director of medical affairs Dr Alisa Niksch said: “Dream Sock is a breakthrough product for the industry and expands our medical-grade monitoring technology to all consumers.

“This device will equip parents of otherwise healthy babies with the real-time data they need to make informed care decisions for their infants. Owlet is dedicated to advancing the capabilities of Dream Sock to enhance care for infants in the home.”

Intended for infants with acute or chronic medical conditions, the BabySat device offers hospital-grade accuracy and is available by prescription only.

It allows healthcare providers to set custom alarms for an infant’s oxygen saturation and pulse rate.

Owlet Healthcare senior vice-president and general manager Jim Fidacaro said: “The launch of BabySat is a huge accomplishment for both parents and providers to enhance care coordination outside of the hospital.

“It extends medical-grade, personalised infant care to the home environment, and with oversight from a physician, parents of babies with health conditions can feel more in control of their little one’s well-being.”

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