Without a splash or fuss, Owlet reintroduced its baby monitoring sock as the Dream Sock last month. Formerly known as the Smart Sock, Owlet got into FDA Hot Water in October [TTA 4 Dec 21] with their marketing the Smart Sock, which monitored sleep patterns, blood oxygen saturation, and pulse rate, as a medical device that would fall under 510(k) marketing clearance requirements, including premarket approval (PMA). The Smart Sock and Smart Duo were pulled from market on 22 November.
The Dream Sock, according to Owlet’s product page, is all about baby sleep, measuring sleep quality indicators, including wakings, heart rate, and movement. It provides a sleep quality score via a sleep coaching app. The difference between the old sock and app is that the blood oxygen saturation (SpO2) measuring capability is deleted. The SpO2 monitoring and the claims they were making were likely causes of the FDA’s warning.
The web store listing is for $299 for a Dream Sock fitting up to 18 months, with the Dream Sock Plus, which fits 0-5 years, at $359. The Dream Duo adds the Cam video baby monitor to the system for babies up to 18 months for $399. Sales are restricted to the US at this time. The products can also be found on the usual web stores.
On both the home page and on the product pages, the disclaimer statement is loud and clear:
WARNING: Owlet products are not medical devices. They are not intended for use as medical devices or to replace medical devices. They do not and are not intended to diagnose, cure, treat, mitigate, alleviate or prevent any disease or health condition, or investigate, replace or modify anatomy or any physiological process. [snip]
Digging into the website, Owlet states that they are “actively pursuing submitting a medical device application to the FDA to bring the Smart Sock technology to medical and consumer markets in the future.”
Owlet shares (OWLT:NYSE) have taken a massive value drop since it completed its SPAC with Sandbridge Acquisition Corporation and parked in the Unicorn Lot last July. It opened at $8, crested to over $10 in mid-August, then started to drop precipitously before Labor Day. It closed on Tuesday at $1.83. If only for the Cute Factor, one wishes them luck.
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