FDA clears Owlet’s pulse oximetry sock for infants

FDA clears Owlet’s pulse-oximetry sock for infants | Image Credit: © Calin - © Calin - stock.adobe.com.

The FDA has cleared BabySat, a pulse-oximetry device for infants designed as a wire-free sock, according to a recent press release from Owlet.¹

According to Owlet, the BabySat can bring “real-time medical grade infant monitoring into the home, while under the supervision of a physician.” The device, cleared on June 20, 2023, is available through prescription. BabySat provides a real-time display of pulse rate and oxygen saturation level (SpO2). If these readings “fall outside of prescribed ranges,” parents are alerted.¹

In 2021, the Smart Sock was pulled from the market following a warning letter from the FDA² stating Owlet failed to receive marketing clearance or approval from the agency.³

In the letter, the agency wrote, “Under section 201(h) of the Act, 21 U.S.C. § 321(h), 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. Products that measure blood oxygen saturation and pulse rate are devices when they are intended to identify (diagnose) desaturation and bradycardia and provide an alarm to notify users that measurements are outside preset values.”³

Under a new name, BabySat will only be available in the United States, with a target date sometime in 2023, according to Owlet.¹

References:

1. FDA clearance; Owlet announces FDA-clearance of first prescription pulse oximetry sock for infants. Owlet. June 20, 2023. Accessed June 23, 2023. https://www.owletcare.com/fda-response
2. Park A. Owlet pulls baby-monitoring Smart Sock from market after FDA warning. FIERCE Biotech. November 29, 2021. Accessed June 23, 2023. https://www.fiercebiotech.com/medtech/owlet-pulls-baby-monitoring-smart-sock-from-market-after-fda-warning
3. Warning letter; Owlet Baby Care, Inc. FDA. October 5, 2021. Accessed June 23, 2023. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/owlet-baby-care-inc-616354-10052021