FDA Allows Owlet to Resume Selling Baby-Monitoring Sock After Two-Year Hiatus
After almost 18 months of being ordered by the FDA to halt the sale of its smart sock, Owlet has regained the trust of the US regulator. The company has been granted clearance for its BabySat product, a wireless “sock” designed for newborns and babies that serves as a medical-grade pulse-ox monitor.
The FDA’s objection was based on the fact that the wearables could transmit a live display of the baby’s heart rate and oxygen levels, which is critical information that should be interpreted by the physician, especially in vulnerable populations. The stormy approval shows that “our technology is medical,” Kurt Workman, Owlet’s CEO and co-founder, said of the company’s path to FDA approval. “We did several side-by-side accuracy comparisons with hospital monitors, and it showed that Owlet is accurate.” The device can alert the provider if any measurements are out of range, which can help diagnose and prevent complications.
Owlet removed the blood oxygen monitoring feature and returned to the market just a few months later with the Dream Sock. It later added an “average oxygen level” reading via a software update. The $299 wearable is available directly from the company and several other retailers without a prescription, but it lacks the advanced features that set it apart from its competitors. Instead, it’s a pretty straightforward sleep tracker.
BabySat, on the other hand, is a prescription device. It integrates medical-grade pulse oximetry technology into a discreet wearable. It’s a non-invasive tool that measures how well oxygen circulates in the limbs of babies aged 1 to 18 months. Without a prescription, a competing medical device cannot easily be found on the market, as BabySat is the first device of its kind. get FDA approval. Making a treatment plan with a doctor is especially valuable and helpful for parents of babies with heart defects or chronic diseases. If a newborn or baby has persistently low oxygen levels, prompt action by medical professionals is needed to prevent life-threatening complications. Owlet expects the product to be available in the US by the end of this year. The company declined to disclose pricing information for BabySat, but said insurance options, including reimbursement and HSA/FSA eligibility, will likely be available at launch. Update June 22, 2023 at 11:35 a.m. ET: This story has been updated to clarify that Owlet’s Dream Sock added average oxygen level monitoring with a software update after it was released.
