A confusing approval

A confusing approval

Normally when the FDA approves a new device it’s a pretty straight forward event but there are exceptions. In our wacky world one of the stranger approvals came when Abbott got an iCGM designation for a CGM that couldn’t be used with automated insulin delivery (AID) systems. Now it seems as if  Abbott is again connected to a strange FDA approval as the Bigfoot Unity has been FDA cleared. But this is no straight forward approval.

From the press release

“Integrated with Abbott’s FreeStyle® Libre 2 system, the Bigfoot Unity System is the first and only to . . .

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