DBLG2 received authorization as a Class II interoperable automated glycemic controller (i-AGC). Clearance validates the algorithm’s interoperability and could bring more choice to people with diabetes, the company said on LinkedIn. It marks the latest milestone for the company’s next-generation algorithm, which follows DBLG1. Diabloop received CE mark approval for DBLG2 in August.

By securing i-AGC status, as well as approval for a Predetermined Change Control Plan (PCCP), the company says it can set “a new standard for agility and safety in automated diabetes management.”