510(k) clearance for the pump hardware
On 11 September 2026 the FDA cleared the Mint ACE pump as an alternate controller enabled insulin pump system. The 510(k) decision rests on substantial equivalence to a device already on the market. The pump is intended for people aged six and older who need insulin, and it requires a prescription.
Reusable unit and disposable cartridge
Mint combines a reusable pump unit with a replaceable cartridge that holds up to 200 units of insulin. A cartridge is intended for three days of wear plus a twelve-hour grace period. Insulin is delivered through a 4.5 millimetre steel cannula. The iLet app controls the system from an iOS or Android phone. According to the manufacturer, the pump does not need to be charged.
The newer dosing algorithm is not yet cleared
The FDA clearance of 11 September 2026 applies to the pump hardware. In the 510(k) summary the FDA describes the system under review as the Mint ACE pump with iLet dosing decision software preinstalled and the iLet app. That describes the cleared hardware. It is not clearance of the new dosing algorithm.
3D Intelligence is a separate dosing algorithm and is not yet cleared. According to the company statement of 14 September 2026, it is meant to offer the care team three options: Original, Optimized and Conservative. On 27 October 2026 Beta Bionics said it had withdrawn the 510(k) for 3D Intelligence after questions from the FDA. A revised submission with additional simulator validation data is planned for the middle of the fourth quarter of 2026. The company expects iLet 3D and Mint 3D in the first half of 2027, possibly as early as the fourth quarter of 2026, in each case only if the FDA clears the algorithm.
The FDA did not require a clinical performance study for the hardware clearance. Insulin delivery was assessed on the bench, and safe use was examined in a human-factors validation. Time in range and hypoglycaemia therefore cannot be inferred from this hardware decision.