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Beta Bionics announced FDA clearance of Mint, its patch pump, and submitted a 510(k) application for 3D Intelligence…
BBNXBeta Bionics, Inc.
Beta Bionics announced FDA clearance of Mint, its patch pump, and submitted a 510(k) application for 3D Intelligence, its next-generation insulin dosing algorithm. The company expects full U.S. commercial launch of Mint in Q1 2027 with manufacturing capacity for at least 1.5 million units in 2027. Revenue guidance for 2026 was lowered to $121–$126 million from $131–$136 million due to anticipated deferral of up to $10 million as customers await Mint. Additionally, a securities class action lawsuit (Holtzman vs. Beta Bionics) was filed on September 4, 2026, alleging misstatements regarding iLet safety and efficacy. Beta Bionics is a medical device company developing automated insulin delivery systems for diabetes management.