Abbott receives FDA OK for over-the-counter glucose monitor

Dive Brief:

Abbott received clearance from the Food and Drug Administration for an over-the-counter glucose monitor.
The device, called Lingo, first debuted in the U.K. last year as a sensor for people who don’t have diabetes to track glucose spikes. Abbott hopes to bring it to the U.S. but has shared few details about its plans.
With the recent FDA clearance, Abbott will compete with Dexcom for a new category of over-the-counter glucose monitors. Dexcom received FDA clearance for the first over-the-counter CGM in March.

Dive Insight:

Abbott has not yet shared when it plans to roll out Lingo, or its strategy for the U.S. market. A company spokesperson wrote in an emailed statement that Abbott is aware of the approval and will provide more details later.

Abbott first rolled out Lingo in the U.K. last summer through a consumer-facing website. The device was intended for people who do not have diabetes, and tracks how many times a person’s blood sugar spikes during the day, CEO Robert Ford said last year.

Earlier this year, Dexcom received clearance for the first over-the-counter CGM, Stelo. A notable aspect of the clearance is that companies must meet the requirements of an integrated CGM for their device to be sold over the counter, meaning the sensor must provide readings that are accurate enough to be used for automated insulin delivery, setting a high bar for potential competitors.

Dexcom’s device is intended for people who have diabetes but do not take insulin, although company leaders also expect people who don’t have diabetes to be interested in the product. Dexcom plans to launch Stelo this summer.

BTIG analyst Marie Thibault, who flagged the FDA clearance, wrote in a research note that the potential clearance could enable Abbott to compete in the over-the-counter market with Dexcom.

“We have not confirmed this with [Abbott] but the company had expected clearance this year and was planning to launch the system under a direct-to-consumer, cash-pay model that does not require a prescription,” wrote Thibault.