Owlet, the company known for its baby monitoring devices, has received clearance from the Food and Drug Administration (FDA) for its latest product, BabySat. This medical-grade pulse-ox monitor is designed as a wireless sock for newborns and babies. The FDA had previously ordered Owlet to stop selling its smart sock almost 18 months ago, citing concerns about the device’s ability to relay a live display of a baby’s heart rate and oxygen levels, which should ideally be interpreted by a doctor, especially for vulnerable populations.
The approval process for Owlet’s product was tumultuous, but it ultimately demonstrated the high quality and accuracy of the technology. Kurt Workman, CEO and co-founder of Owlet, stated that the company conducted several accuracy comparisons to hospital monitors, proving that Owlet is accurate. The device can alert healthcare providers if any metrics are out of range, aiding in the diagnosis and prevention of complications.
In response to the FDA’s concerns, Owlet removed the blood oxygen tracking feature and relaunched the product as the Dream Sock. Through a software update, they later added an ‘average oxygen level’ readout. Priced at $299, the Dream Sock is available directly from the company and other retailers without a prescription. However, it lacks the advanced features that set it apart from its rivals, functioning primarily as a sleep tracker.
On the other hand, BabySat is a prescription device that integrates medical-grade pulse oximetry technology into a discreet wearable. It provides a noninvasive method to measure how well oxygen is circulating to extremities in babies between the ages of 1 and 18 months. As the first device of its kind to receive FDA approval, it is not readily available on the market without a prescription.
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The approval of BabySat has significant implications for parents whose babies have been diagnosed with heart defects or chronic conditions. With the help of a doctor, they can create a treatment plan and closely monitor their baby’s oxygen levels. If persistent low oxygen levels are detected, quick intervention by medical professionals is crucial to prevent life-threatening complications.
Owlet expects BabySat to be available in the US by the end of the year. Although pricing information has not been disclosed, the company has indicated that insurance options, including reimbursements and eligibility for health savings accounts or flexible spending accounts, will likely be available at launch.
In summary, Owlet’s BabySat has received FDA clearance, marking a significant milestone for the company. The medical-grade pulse-ox monitor offers parents a valuable tool to monitor their baby’s oxygen levels discreetly and accurately. While Owlet’s Dream Sock continues to be a popular sleep tracker, BabySat stands out as a prescription device with advanced features that cater to babies with specific medical conditions. With the anticipated availability of BabySat in the near future, parents can look forward to improved monitoring and peace of mind.
