Two FDA clearances add diabetes technology options

Two diabetes management devices that aid in the precision of insulin delivery have been recently cleared by the U.S. Food and Drug Administration (FDA).

On March 2, the FDA cleared the Android version of Bigfoot Biomedical’s Unity Mobile App for use with its system of smart pen caps that are compatible with different disposable insulin pens for administering both long-acting and rapid-acting insulin. The system is “the first and only FDA-cleared smart injection system that turns CGM [continuous glucose monitoring] data into dosing recommendations displayed right on the pen cap for people using multiple daily [insulin] injection therapy,” according to a company statement. Once it is commercially launched, the Android phone application will be available via the Google Play Store.

On March 6, the FDA also cleared the Abbott FreeStyle Libre versions 2 and 3 devices as “integrated” CGM sensors. This means that they can now be used as components in automated insulin delivery systems, along with insulin pumps and connectivity software. Indeed, Abbott is already working with insulin pump manufacturers Insulet and Tandem in the United States for integration with the FreeStyle Libre versions 2 and 3. The modified sensors will be available in the US later this year and will eventually replace the Libre sensors in current use.

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