Beta Bionics Inc., an Irvine-based maker of automated insulin delivery systems for diabetes, received FDA clearance for its Mint patch pump.
The company also submitted a 510(k) application for a next-generation insulin dosing algorithm.
Beta expects to begin commercializing Mint in the U.S. in the first quarter of 2027.
The company additionally lowered its full-year revenue guidance to $121 million to $126 million from its previous forecast of $131 million to $136 million, citing prospective customers waiting for the Mint launch.
Shares in Beta rose 3.4% to $17.14 apiece with a market cap of $769 million (Nasdaq: BBNX).