Beta Bionics gets FDA clearance for Mint patch pump, cuts 2026 outlook
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Beta Bionics Announces FDA Clearance of Mint™, the Company’s Transformative Patch Pump, and Unveils 3D Intelligence™ as its Next-Generation Insulin Dosing Algorithm
September 14, 2026 7:30 AM EDTMint features a new and innovative patch pump architecture Full Mint U.S. commercialization expected to begin in Q1 2027 Manufacturing capacity expected to produce at least 1.5 million disposable Mint units during 20273D Intelligence, the Companys next-generation insulin dosing algorithm, has been submitted to the FDA through a 510(k) applicationExpectations to commercialize 3D Intelligence in the U.S. by the end of 2026 as iLet 3D, and at the time of full Mint launch as Mint 3D, subject to regulatory clearance by the FDAUpdated full year... More
