FDA approves Owlet’s baby-monitoring sock two years after halting sales

Owlet and its baby monitoring devices are back in the good graces of the FDA. The company received clearance from the US regulator for its product BabySat, a medical-grade pulse-ox monitor designed as a wireless “sock” for newborns and babies. The win comes after the FDA ordered the Utah-based biotech company to stop selling its smart sock almost 18 months ago.

The FDA objection was based on the fact that the wearable had the capacity to relay a live display of a baby’s heart rate and oxygen levels, which is critical data that a doctor should interpret, especially in vulnerable populations. The tumultuous approval demonstrates “our technology is medical-grade,” Kurt Workman, Owlet CEO and co-founder said of the company's path to getting FDA approval. “We conducted several side-by-side accuracy comparisons to hospital monitors and that demonstrated Owlet is accurate." The device can alert a provider if any metrics are out of range, which can help to diagnose and prevent complications.

Owlet stripped out the blood oxygen tracking feature and returned to the market just a few months later with the Dream Sock. It later added in an ‘average oxygen level’ readout through a software update. The $299 wearable is available direct from the company and through a number of other retailers without a prescription, but it lacks the advanced features that set it apart from the rest of its rivals. 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 noninvasive tool to measure how well oxygen is circulating to extremities in babies from 1 to 18 months.

Without a prescription, a rival medical-grade device can not be readily found on the market, given that BabySat is the first device of its kind to receive FDA approval. Creating a treatment plan with a doctor is especially valuable and useful to the parents of babies that have been diagnosed with heart defects or chronic conditions. If a newborn or baby does present with persistent low oxygen levels, quick intervention by medical professionals is needed to prevent life-threatening complications.

Owlet anticipates the product will be available in the US by the end of this year. The company declined to disclose pricing information for BabySat but did say that insurance options, including reimbursements and HSA/FSA eligibility, will likely be available at launch.

Update, June 22nd, 2023, 11:35 AM ET: This story has been updated to clarify that Owlet’s Dream Sock added average oxygen level tracking through a software update after its launch.