Beta Bionics has announced that its patch pump, Mint, is expected to reach full commercialization by the end of Q2 2027, pending FDA clearance of its 510(k) application.
The timeline reflects recent FDA feedback as well as scaling-up manufacturing to ensure the initial demand can be met at launch.
Powered by Beta Bionics' FDA-approved iAGC algorithm, Mint is a two-piece, waterproof patch pump with a 200-unit insulin reservoir, a three-day wear period plus a 12-hour grace period, and no recharging required. It supports iOS and Android control and is compatible with the Dexcom G7, Dexcom G7 15-Day, and Libre 3 Plus. The device will be sold through the pharmacy channel, with Beta Bionics leveraging existing iLet coverage arrangements to expand reimbursement.
Omnipod currently leads the tubeless pump market, but competition is growing. Tandem Diabetes is developing a tubeless version of Mobi, and MiniMed is working on MiniMed Fit.
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