FDA Clears Mint Patch Pump; 3D Insulin Algorithm Submitted

Beta Bionics announced FDA clearance of Mint, its patch pump with a two-piece reusable and disposable architecture, in a September 14 press release. The company expects full US commercialization in the first quarter of 2027. The company expects Mint to support selected continuous glucose monitors and iOS and Android smartphone control without requiring recharging.

The company expects to launch Mint exclusively through the pharmacy channel. Beta Bionics estimated that approximately 40% of insured US lives would be able to purchase the pump using a pharmacy benefit at launch, with coverage rising to at least 50% within the first year of full commercialization. The company anticipates manufacturing at least 1.5 million disposable units in 2027.

Planned Mint 3D specifications include three days of wear with a 12-hour grace period, a 200-unit insulin reservoir, and an IPX8 rating for immersion up to 5 feet for 60 minutes. Expected compatible monitors are the Dexcom G7, Dexcom G7 15 Day, and Abbott FreeStyle Libre 3 Plus. These features may change, the release noted.

Beta Bionics also said it submitted 3D Intelligence, its next-generation insulin dosing algorithm, to the FDA through a 510(k) application. The algorithm is designed to provide three clinician-selectable experiences: Original, which is currently available with iLet; Optimized, which incorporates lessons from the company’s iLet experience; and Conservative, which is intended to provide a more measured response when correcting high glucose levels.

Subject to FDA clearance, 3D Intelligence is expected to power iLet 3D and Mint 3D. Beta Bionics expects to commercialize iLet 3D in the United States by the end of 2026 and Mint 3D with the full Mint launch in the first quarter of 2027. The company said iLet 3D and Mint 3D are investigational and unavailable for sale, and that product features may vary.

Source: Beta Bionics, Inc. Beta Bionics announces FDA clearance of Mint™, the company’s transformative patch pump, and unveils 3D Intelligence™ as its next-generation insulin dosing algorithm. Press release. Beta Bionics, Inc.; September 14, 2026. Accessed September 16, 2026.