FDA cleared Beta Bionics' Mint patch pump on September 14. The tubeless pump pairs a reusable controller with a disposable pod that holds 200 units of insulin. It runs three days plus a 12 hour grace period and carries an IPX8 waterproof rating. It works with the Dexcom G7 and the Abbott FreeStyle Libre 3 Plus, and runs from an iOS or Android phone.
Beta Bionics plans full US commercialization in the first quarter of 2027, through the pharmacy channel only. It expects about 40 percent of insured US lives to have coverage at launch and at least 50 percent within the first year. Manufacturing plans call for at least 1.5 million disposable pods in 2027.
The Irvine, California company cut 2026 revenue guidance the same day, to $121M to $126M from $131M to $136M. It put roughly $10M of that on fourth quarter orders customers are expected to defer until Mint ships.
Beta Bionics also submitted a 510(k) for 3D Intelligence, its next insulin dosing algorithm, with Original, Optimized and Conservative settings. The guidance cut is the practical lesson here. Clearing a better product you cannot ship yet pulls revenue out of the current year. That gap between decision letter and first shipment belongs in the model alongside the review clock.