Owlet Seeks Authorization for Baby Sock That Measures Blood Oxygen After FDA Warning Letter

Diving brief:

  • Owlet filed a 510(k) premarket notification for a prescription-only medical device that checks babies’ blood oxygen.
  • The company received a warning letter from the Food and Drug Administration last year after the agency concluded that a so-called Owlet smart sock sold to measure pulse and blood oxygen in babies was a medical device.
  • Owl replied with stopping the sale of his sock in the United States, resulting in a $13 million repayment liabilityand advancing his existing plans to launch a product for the home healthcare market.

Overview of the dive:

The filing of the 510(k) notification brings Owlet closer to the possibility of selling a prescription medical device designed to alert parents when their baby’s heart rate or oxygen saturation levels fall outside prescribed ranges.

News of the notification comes a year after the Food & Drug Administration issued a warning letter accusing Owlet of selling a medical device without authorization or approval. The situation with the FDA predates the warning letter with owl revealing during its special purpose acquisition company merger in the summer of 2021, that the agency disagreed with its conclusion that the smart sock was not a medical device.

While Owlet flagged the risk that the FDA could force it to stop selling the device, some investors responded to the warning letter by suing the company. Two putative class action lawsuits have been filed in November 2021. The warning letter also resulted in Owlet agreeing to allow certain customers and retailers to return the smart sock, resulting in the accrual of a refund obligation.

Owlet has already made a different sock available to consumers. This wraps around a baby’s foot and tracks wakefulness, movement, and heart rate, all can be monitored on an ordinary smart phone. The company threw the sock earlier this year after concluding that the product meets FDA guidelines for general well-being.

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