Two novel device or indication approvals were added to Medtech Insight's Approvals Tracker last week. Among them, Tandem Diabetes Care Inc. netted a first with US FDA. On Feb. 14, the agency granted a de novo classification to a version of Tandem's t:Slim X2 insulin pump with technology allowing it to be used with a variety of different components that make up diabetes therapy systems.
Previously, insulin pumps have either been cleared as completely standalone devices or as part of a single, predefined diabetes management system that incudes a continuous glucose monitor (CGM). and other...