U.S. FDA clears new version of Abbott’s low-cost glucose monitor

(Reuters) – The U.S. Food and Drug Administration on Monday cleared a new version of Abbott Laboratories’ continuous glucose monitoring device, helping the company build upon the success of its fastest-growing diabetes product.

FreeStyle Libre 2, which was approved in Europe in 2018, will be priced the same as its precursor and is offered at a discount compared to rival devices, Abbott said.

Medical devices maker DexCom Inc’s shares fell 1.4% to $365 in premarket trading, while Abbott’s stock was flat.

Accuracy of the data from Abbott’s device looks better than Dexcom’s rival glucose monitor, Evercore ISI analyst Vijay Kumar said.

“It will be interesting to see how payers (health insurers) react to this data given that Libre 2 is priced at a meaningful discount to Dexcom,” Kumar added.

The first generation of the device, which has brought in millions in sales for Abbott, allows diabetics to track their blood sugar levels without multiple daily finger sticks.

Each Libre 2 device sensor, worn at the back of the upper arm for 14 days, will be available at a list price of $54, while a handheld reader, used to scan the sensor, will be available for a one-time cost of $70.

Commercially-insured patients can pay as low as $10 out-of-pocket per month for two sensors, Abbott said.

Worldwide sales of Freestyle Libre devices rose 58.5% to $534 million in the fourth quarter of 2019. The company last year said it planned to ramp up manufacturing capacity for the device by three to five times in the next few years.

Libre 2 would be produced on the same manufacturing lines as the first version, Jared Watkin, Abbott’s senior vice president for diabetes care said.