Abbott secures FDA clearance for over-the-counter glucose monitor

USA – Abbott has secured a clearance from the FDA for its over-the-counter Lingo glucose-monitoring biowearable. 

According to a listing on the FDA’s website, the 510(k) clearance came on May 29. 

An Abbott spokesperson confirmed the approval and said the company would provide more details later.

Last year, Abbott launched Lingo in the U.K., targeting people without diabetes who want to track glucose spikes. 

The device tracks how the body reacts to food, sleep, and exercise, aiming to help users minimize glucose spikes throughout the day. Through the sensor, Lingo learns about the user’s metabolism and assigns a daily target.

The clearance marks a significant milestone for Abbott, as it competes with Dexcom, which received FDA clearance for its Stelo over-the-counter CGM in March. 

Dexcom’s Stelo is designed for people with Type 2 diabetes and those who want to track their blood sugar levels. Both companies are excited about the potential for selling CGMs to athletes and others who may not have diabetes but find benefits in monitoring their blood glucose.

The growth of the CGM market is expected to be substantial. 

William Blair analyst Margaret Kaczor predicts that the domestic CGM market could reach US$7.8 billion-plus in 2025 and US$10.3 billion in 2027 due to the addition of nearly 300,000 new non-insulin CGM users, compared to a projection of 200,000.

Abbott CEO Robert Ford has expressed enthusiasm about Lingo, calling it a growth driver for the company’s business. 

He emphasized that the technology is not just for people with diabetes but for anyone who wants to understand their glucose levels better. 

Ford stated, “We’re taking this wearable technology and moving it beyond diabetes and into the personalized consumer health market. Ultimately, we want this technology to be available to everybody. We’re excited about the opportunity to bring Lingo to the U.S. market soon”.

The FDA clearance for Lingo comes as the market for biosensors becomes more accessible. 

Biosensors are wearable devices that track health metrics, such as glucose levels, and are designed for people without diabetes. 

The clearance of Stelo and Lingo reflects a growing interest in glucose tracking and biosensing technology, which could potentially help prevent health conditions like Type 2 diabetes.

Abbott’s Lingo and Dexcom’s Stelo are part of a new category of over-the-counter glucose monitors that can be purchased without a prescription. 

This shift is expected to expand access to these devices, making them more widely available to individuals who want to track their glucose levels.

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