The FDA has approved the first over the counter continuous glucose monitor designed specifically for children.

The Food and Drug Administration announced Friday that it has cleared the first over the counter continuous glucose monitor designed specifically for children, a move that expands access to a technology that has already transformed diabetes management for adults. Continuous glucose monitors use a small sensor worn on the skin to track blood sugar levels throughout the day and night, sending real-time data to a smartphone or receiver without the need for repeated finger-prick testing.

Until now, continuous glucose monitors approved for use in children typically required a prescription, creating an additional barrier for families seeking to monitor a child's blood sugar for reasons ranging from diagnosed diabetes to general health monitoring. By clearing an over-the-counter version, the FDA is opening the door for these devices to be sold directly to consumers without a doctor's visit, potentially lowering costs and improving access, particularly for families in areas with limited specialist care.

The announcement is part of a broader wave of FDA activity this month, which has also included expanded sunscreen options for the first time in 20 years and new draft guidance aimed at accelerating cell and gene therapies. For medical device makers, the clearance represents a significant expansion of the addressable market for glucose monitoring technology, a sector that has grown rapidly as wearable health devices become more mainstream among both diagnosed patients and health-conscious consumers more broadly.