Keyword: Bigfoot Biomedical
The involvement of Abbott and other investors means Bigfoot has $55 million to take its insulin pump and pen through clinical development.
The clearance marks the first time the FDA has signed off on such an integrated system and creates a simpler path to market for future CGMs.
CMS covers traditional insulin pumps, but not tubeless patch pumps, causing concern around innovation as well as patient access.
The series B gives Bigfoot the financial muscle to move its automated insulin infusion device into a pivotal clinical trial in the U.S. next year.
The agreement sets Bigfoot up to start a pivotal trial of a version of its delivery system that incorporates the Abbott technology next year.
Bigfoot Biomedical reeled in $35.5 million in Series A funding, which it will use to push its automated insulin delivery service through the last stages of development.