Owlet, the renowned baby monitoring device company, has regained approval from the US 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, providing accurate and vital health data. The clearance comes after the FDA previously ordered Owlet to cease selling its smart sock nearly 18 months ago.
The FDA had raised concerns about the device’s capability to display a live feed of a baby’s heart rate and oxygen levels, which are critical metrics requiring interpretation by healthcare professionals, particularly in vulnerable populations. The recent approval signifies the recognition of Owlet’s technology as medical-grade, according to Kurt Workman, Owlet’s CEO and co-founder. Owlet conducted rigorous accuracy comparisons with hospital monitors to demonstrate the reliability and precision of their device. With the ability to alert healthcare providers about any abnormal metrics, BabySat can aid in diagnosing and preventing potential complications.
In response to the FDA’s objection, Owlet modified its product, removing the blood oxygen tracking feature, and subsequently re-entered the market with the Dream Sock. Over time, the company added an “average oxygen level” readout through a software update. Priced at $299, the Dream Sock serves as a straightforward sleep tracker, lacking the advanced features that differentiated the original Owlet smart sock from competitors. It is available for purchase without a prescription directly from Owlet and various retailers.
On the other hand, BabySat is a prescription device that integrates medical-grade pulse oximetry technology into a discreet wearable. It provides noninvasive measurement of oxygen circulation to extremities in infants aged 1 to 18 months. As the first device of its kind to receive FDA approval, it stands apart from other non-prescription medical-grade alternatives. The availability of BabySat with a prescription is particularly valuable for parents whose babies have been diagnosed with heart defects or chronic conditions. Prompt intervention by medical professionals is crucial if a newborn or baby exhibits persistent low oxygen levels to prevent potentially life-threatening complications.
Owlet expects to make BabySat available in the United States by the end of this year. Pricing details for BabySat have not been disclosed yet, but the company anticipates that insurance options, including reimbursements and eligibility for health savings accounts (HSA) or flexible spending accounts (FSA), will likely be offered upon launch. Owlet’s commitment to providing innovative and reliable baby monitoring solutions, now with the FDA’s renewed approval, reinforces its position as a trusted brand in the market.
