After FDA warning owlet puts smart baby monitoring socks on hold. The company has also hinted at its plans to roll out a new product line of sleep monitoring solutions soon.
After FDA Warning Owlet Puts Smart Baby Monitoring Socks On Hold
Owlet has quit selling its setup of a smart child observing socks, which should follow a child’s important bodily functions and rest designs, subsequent to getting a notice letter from the Food and Drug Administration (FDA).
First revealed by Deseret News, the FDA’s letter expresses that Owlet’s Smart Socks are viewed as clinical gadgets, as they give pulse and oxygen level notices, and that the organization has been selling them without the legitimate “marketing approval, clearance, or authorization” from the FDA.
FDA’s Reasons for Its Warnings
The product company, owlet has already removed its line of smart socks as well as any other product bundle that includes the device from its website. The product page of the smart socks reads “the owlet sock family of products is currently unavailable. Check back in the coming weeks to see the newest addition to the nest.”
However, the smart socks from owlet are still available on other online marketplaces such as Amazon, BuyBuyBaby, and Bed Bath and Beyond. Outside the US, smart socks from owlet is still available for purchase.
The FDA already explained that smart socks are medical devices. And the reason for the claim is that it measures blood oxygen saturation and heart rate with the intent to “identify desaturation and bradycardia and provide an alarm to notify users that measurements are outside preset values.”
Previously, the owlet product company has mentioned that smart socks are low-risk products and not medical products and devices. The FDA apparently has been notifying the company about the issue as they see the product as a medical device since 2016.
Owlet already has posted a response to the FDA on its website. The company noted that it plans to carry out the requests of the agency and will also seek marketing approval for its other features and products that track heart rate and oxygen levels.
On the company’s website, it also said that the FDA did not “identify any safety concerns about the smart sock” and it also reassures users and owners of the sock that “there has not been any change” to the product’s functionality.
How Safe Is Owlets Smart Sock
Owlet has already backed the safety of the products saying that the “smart sock’s safety has been validated by third parties, in which it was shown to be safe.” The company also said that “in addition, the letter we received from the agency (the FDA) did not identify any safety concern about the smart sock.”
The company hinted at introducing similar products in its letter. In the letter, the company stated that it plans on offering “a new sleep monitoring solution,” one that will be available soon. In similar scenarios, smart baby monitors like owlets’ smart cocks have been criticized.
Doctors and experts in the field have claimed that these products may actually put infants at risk due to the fact that they are not classified as medical devices and are also not subject to major oversight and regulations.
