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FDA News: System Approval, Plant-Based Milk Labeling…

US FDA News Roundup

In a recent U.S. Food and Drug Administration (FDA) news summary, several vital updates were announced, including approving the MiniMed 780G System, reopening the comment period for plant-based milk labeling, and the clearance of the Selux AST System.

The FDA approved the MiniMed 780G System, which now includes SmartGuard (SG) Technology modifications and expands indications to incorporate the Guardian 4 Sensor. Designed for type 1 diabetes mellitus management in individuals aged seven years and older, the MiniMed 780G system delivers continuous basal insulin. It monitors glucose values in the fluid under the skin. The system’s SG technology can automatically adjust insulin delivery based on glucose values and suspend delivery when values drop below predefined thresholds. The new Advanced Hybrid Closed Loop algorithm also enables automatic correction of insulin boluses without user input.

The FDA announced that it would reopen the comment period for draft guidance on labeling plant-based milk alternatives, responding to stakeholder requests for additional time to develop and submit comments. A new deadline will be determined once the reopening notice is published.

The FDA authorized the Bateman Bottle Breast Implant Removal System (BIRS) for marketing. This single-use suction device assists in removing intracapsular ruptured silicone breast implants but is not intended for en bloc removal or direct application to tissue.

The FDA released new educational materials for the “Feed Your Mind” initiative, which provides science-based information on genetically modified organisms (GMOs). The materials were developed in collaboration with the USDA and the U.S. EPA.

Lastly, the FDA granted clearance for the Selux AST System to be used with the Selux Gram-Negative Comprehensive Panel. This in vitro diagnostic test system is used for antimicrobial susceptibility testing, allowing simultaneous testing of numerous drugs and drug concentrations, and is designed to help physicians select the most effective treatments for infections.

Image provided by the FDA

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