May 10, 2021
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 . . .
This content is restricted to subscribers. Please subscribe.
Already have an account? Please login.