U.S. FDA clears version 2.0 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, FreeStyle Libre, 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.

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. It was launched in Europe in 2014 and three years later in the U.S.

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

Commercially-insured patients will pay about $10 out-of-pocket per month for two sensors.

Worldwide sales of the Freestyle Libre device 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.

FreeStyle 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.

Reporting by Manas Mishra in Bengaluru; Editing by Shounak Dasgupta

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source: reuters.com