Owlet announced on November 23, 2021 it has suspended sales of its first and flagship product, Smart Sock, a pulse-oximeter device, a tiny sock worn by an infant to track key data at night such as heart rate, oxygen levels and sleep patterns. The Lehi-based company went public last July under the ticker symbol OWLT as reported by TechBuzz. Shares of the company traded somewhat steadily at just under $10/share over several weeks post-IPO then dipped to below $7 in late August and gradually declined to below $4 per share in recent weeks. Share closed today up 10% at $4.27.

Owlet has sold over one million of the infant monitors in the last six years and has gathered research data that exists nowhere else. The company has twelve ongoing research studies, including one with the Cleveland Clinic, as reported in an earlier TechBuzz article. 

The Food and Drug Administration claims Owlet is violating federal guidelines and may not sell the product, as the FDA considers it a “medical device” due to its ability to monitor pulse and oxygen levels. 

Owlet published the following response on its website:

Owlet received a Warning Letter from the FDA regarding the Smart Sock’s regulatory status in the United States. The letter we received from the agency did not identify any safety concerns about the Smart Sock; rather, the FDA asserts that the Smart Sock should be classified as a medical device in the U.S. because of the heart rate and oxygen notifications. Based on the FDA’s recent letter, Owlet plans to pursue marketing authorization from the FDA for these features.

As a result of the letter and in light of our plans to submit a device application to the FDA, we will no longer be selling the Smart Sock. We plan to offer a new sleep monitoring solution, which we believe will be available soon. We also plan to continue to support our current customers. There has not been any change to your product’s functionality or a request from the FDA to exchange or return your product at this time. We will notify customers of any updates to the Smart Sock products that have already been distributed. This action is specific to the U.S. only and no other countries or regions are affected by this.

With over 1 million babies monitored, we are extremely proud of the innovation and technology Owlet has delivered. We will continue to stay focused on our mission and are cooperating with the FDA so we can continue to provide sleep monitoring products and solutions to parents and babies. 

The company assures customers the functionality of the Smart Sock has not changed and reminds them that the sock's safety has been validated by third parties (safety was never a concern mentioned in the FDA notice). Owlet says it will notify customers of any updates to Smart Sock products already in use. It also tells its customers the company plans to work towards submitting the Smart Sock application to be considered a medical device and plans to meet with the FDA soon.

A Change.org petition has emerged and has amassed over 60,000 signatures (as of this writing), over 10,000 of which were added just today. It is striving to reach 75,000 signatures to achieve "Top Signed On" status.

"I am a board certified physician." said one of the signers of the petition. "The FDA has acted unfairly in their interactions with Owlet since the beginning. To come after them now is unfair and disingenuous. I feel strongly that their recent actions should be reconsidered."

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