Abbott Laboratories Monday said the U.S. Food and Drug Administration has cleared for sale two new over-the-counter continuous glucose monitoring systems, devices that could bring more access to millions of people with diabetes.
Abbott’s said its Lingo device is designed for general consumers who are looking to improve their overall health and wellness while the other device cleared by the FDA known as Rio is for adults with Type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications.
“There is no one-size-fits all approach for glucose monitoring, which is why we’ve designed different products for different people – all based on the same world-leading biowearable technology1,” said Lisa Earnhardt, executive vice president and group president of Abbott’s medical devices business. “People living with diabetes need certain features like tracking medications or sharing data with a healthcare provider. People without diabetes need different features to manage their metabolic health, including personalized coaching to promote actionable lifestyle changes.”
The approvals come as Abbott, which already has a top-selling continuous glucose monitor for diabetes management known as Libre that generates more than $4 billion in sales annually, is developing a new line of biowearables including Lingo and Rio that track glucose levels, ketones and lactate.
This new category of consumer biowearables, which attach beneath the skin to give more precise and accurate data about what is going on in someone’s body, is the latest evolution in medical devices for Abbott. The healthcare company is already known for its nutritionals franchise led by Similac baby formula, established pharmaceuticals and diagnostic tests for everything from the HIV virus and cancer to its top-selling array of tests for Covid viruses and its latest variants.
Abbott chief executive Robert Ford opened a window into the company’s push to bring biowearables to the market at last year’s HLTH conference in Las Vegas during a keynote address.
“We are creating a new consumer biowearable that not only tracks your glucose levels, but, using AI, delivers a personalized coaching plan to help you develop healthier habits, and motivate you to do the hardest thing: modify and adapt your behaviors and habits,” Abbott chief executive Robert Ford said at HLTH 2023 in Las Vegas.
Ford highlighted the differences between Lingo and the company’s already top-selling Libre franchise.
“Lingo starts by establishing a baseline reading of your body’s glucose levels and their fluctuations through the sensor that is worn on your arm,” Ford said. “The tech assesses how your diet, exercise, sleep, and other factors affect your glucose. And that is unique to each person.”
