The clearance came on May 29, according to a listing on the FDA’s website. An Abbott spokesperson said the company was aware of the clearance and would provide more details later.
FDA clearance for Abbott’s Lingo comes more than two months after Dexcom won clearance for its Stelo over-the-counter CGM. Officials at both companies have expressed excitement over selling CMGs to athletes and others who may not have diabetes but find benefits from tracking their blood glucose.
William Blair analyst Margaret Kaczor was surprised in April that the companies added nearly 300,000 new non-insulin CGM users, compared to a projection of 200,000. According to Kaczor’s report, the growth could boost the domestic CGM market to $7.8 billion-plus in 2025 and $10.3 billion in 2027.
Abbott’s Lingo tells users about glucose spikes and how their body reacts to food, sleep and exercise. The goal is to enable users to better minimize those spikes throughout the day. Lingo learns about the user’s metabolism through the sensor and then assigns a daily target.
Abbott launched Lingo in the U.K. last year. Abbott CEO Robert Ford has expressed excitement over Lingo as yet another growth driver for the company’s business.
At the J.P. Morgan Healthcare Conference in January, Ford said Lingo users find the Lingo system engaging, enjoyable, educational and, most importantly, “life-changing.”
“We’re taking this wearable technology and moving it beyond diabetes and into the personalized consumer health market,” Ford said. “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.”
