FDA Clears DexCom Stelo Glucose Biosensor for Children Ages 2 and Older Not Using Insulin

Beta Bionics secured FDA clearance for its Mint patch pump, marking the company's entry into the tubeless patch pump market alongside its existing iLet automated insulin delivery platform. The company also unveiled its next-generation 3D Intelligence insulin dosing algorithm, which has been submitted to the FDA through the 510(k) pathway and is currently under review. Beta Bionics lowered its full-year 2026 revenue guidance to $121-$126 million from the previous $131-$136 million, citing the possibility that prospective iLet customers may delay purchases ahead of Mint's launch, while gross margin guidance for 2026 remains unchanged at 58.5%-59.5%. The company expects to begin full U.S. commercialization of Mint in the first quarter of 2027, earlier than previously targeted, with manufacturing capacity of at least 1.5 million disposable units during the year, and expects to commercialize iLet 3D by the end of 2026 with Mint 3D launching alongside the full U.S. rollout of Mint. Mint is likely to launch exclusively through the pharmacy channel, where roughly 40% of insured U.S. lives are expected to have initial access, with coverage anticipated to expand to at least 50% within the first year. Shares of BBNX surged more than 15% following the announcement; the stock has lost 27.2% year to date, and the company currently has a market capitalization of $865.2 million.

Medtronic raised the lower end of its fiscal 2027 profit forecast and lifted its revenue growth outlook, citing strong demand for heart devices used in complex cardiovascular procedures. The Ireland-based company raised the lower end of its adjusted per-share profit forecast to $5.94 from $5.90 while keeping the upper end at $6.00, against an analyst average of $5.95, and now expects annual organic revenue growth of 7.25% to 7.75%, up from 6.75% to 7.25% previously. First-quarter fiscal 2027 revenue reached $9.756 billion, up 13.7% both reported and organically, beating the $9.55 billion analyst consensus, with adjusted earnings per share of $1.45 topping the $1.39 estimate. Growth was broad-based across segments, with Cardiovascular revenue up 19.5%, Diabetes up 16.9%, Neuroscience up 10.3%, and Medical Surgical up 10.0%, though Medtronic said about $570 million of the quarter's growth came from an extra week in the reporting period. The guidance still includes the diabetes business, which Medtronic has said it may fully separate before fiscal year-end, though CFO Thierry Pieton said the company is not under pressure to rush that timeline.

Beta Bionics' estimated fair value has been lifted to about US$21.67 from roughly US$19.80, a revision tied to Wall Street research reassessing the company's pipeline, its expected patch pump entry and the timing of its Type 2 diabetes and fully closed loop indications. Several firms, including Truist, UBS, Leerink and Goldman Sachs, have raised their price targets on the stock, with Truist and UBS pointing to FDA clearance of the Mint patch pump and updated launch timing as key execution milestones as Mint enters the patch pump segment as an alternative to Omnipod. UBS and BofA cited clearer timelines for the Type 2 diabetes and fully closed loop indications, while Truist pointed to survey work suggesting Beta Bionics is gaining share, with iLet screening well for pump naive patients entering the market. Not all research moved in the same direction: Baird and BofA kept Neutral ratings despite higher targets, William Blair initiated at Market Perform and flagged the stock's premium valuation versus Tandem Diabetes, and Ladenburg trimmed its target to US$30.40 from US$32. Behind the fair value change, the model's revenue growth input shifted to about 37.32% from about 35.78%, the net profit margin assumption moved to about 12.58% from about 11.76%, the future P/E assumption adjusted to about 33.33x from about 36.27x, and the discount rate rose to about 7.48% from about 7.38%.