The FDA has cleared two new over-the-counter glucose monitoring devices, expanding its presence in a fast-growing, multi-billion-dollar market.
The devices, one for the health-conscious and another for those with diabetes, follow FreeStyle Libre, which generates over $1 billion every quarter and is sold under prescription for patients with diabetes.
One of the new OTC devices, Libre Rio, is intended for the 24.5 million patients with type 2 diabetes who do not use insulin and typically manage their diabetes through lifestyle modifications, said RBC Capital Market analyst Shagun Singh.
The second product, Lingo, will help to track glucose and provide personalized insights to improve overall well-being.
The device manufacturer, Abbott Laboratories, plans to launch Lingo this summer, a spokesperson said, without disclosing details on pricing. Lingo has been available in Britain since January for 120-150 pounds ($152-$190) per month.
The new devices combined can be at least a $1 billion plus in annual sales opportunity as a first stop, the Singh said.
Libre Rio and Lingo will compete with Dexcom's Stelo, which in March became the first continuous glucose monitor to be approved by the FDA for OTC sales.
Shares of Abbott were up about 1% in morning trade on Monday.