Abbott Laboratories has received clearance from the U.S. Food and Drug Administration (FDA) to sell its Lingo glucose monitor over the counter, without a prescription. The clearance, which came on May 29 according to the FDA’s website, positions Abbott to compete with Dexcom in the emerging market for glucose monitoring devices aimed at people without diabetes.

Lingo first launched in the U.K. last year as a wellness device that helps users track glucose spikes and understand how their body responds to factors like diet, sleep, and exercise. The wearable sensor assigns personalized daily glucose targets as it learns about the individual’s metabolism over time. Abbott CEO Robert Ford has expressed excitement about Lingo’s potential to bring glucose monitoring “beyond diabetes and into the personalized consumer health market.”

The FDA clearance comes just months after Dexcom received the first-ever approval for an over-the-counter continuous glucose monitor (CGM), the Dexcom Stelo, in March. Both companies see significant growth potential in marketing CGMs to health-conscious consumers like athletes who don’t have diabetes but are interested in optimizing their metabolic health.

Analyst estimates suggest this market expansion could boost the domestic CGM market to over $7.8 billion by 2025. In April, Abbott and Dexcom reportedly added nearly 300,000 new CGM users who don’t take insulin – far exceeding projections of 200,000.

While Abbott has not yet announced a U.S. launch timeline for Lingo, CEO Robert Ford stated in January that user feedback from the U.K. rollout has been very positive, with many finding it engaging, educational and “life-changing.” As more consumers gain access to personalized glucose data, it could mark an important step forward for preventive health and wellness technology.

This article was originally published on iBIO NewsBrief. Gain a head start on your day with iBIO NewsBrief. Subscribe to receive top industry headlines delivered straight to your inbox.

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