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Beta Bionics insulin patch pump scores FDA clearance

September 15, 2026 By Conor Hale

Beta Bionics Mint automated insulin delivery Patch Pump product image
The Mint patch pump system [Image courtesy of Beta Bionics]
Beta Bionics (NASDAQ: BBNX) has claimed an FDA clearance for its first patch pump insulin delivery system, amid plans to roll out an updated diabetes dosing algorithm and the launch of a new CGM partnership with Senseonics.

The three-day, wearable Mint carries a 200-unit insulin reservoir as well as a combination of reusable and disposable hardware, and is designed to never need recharging. Beta Bionics also bills it as smaller than the leading patch pump, rival Insulet’s Omnipod 5.

The company said it plans to produce at least 1.5 million disposable units during the next calendar year, following an earlier-than-expected U.S. commercial launch in the first quarter of 2027 aimed exclusively at pharmacy shelves. Beta Bionics had previously pegged Q2  for Mint’s launch.

Controlled by a smartphone app, the Mint will start by being compatible with Abbott’s FreeStyle Libre 3 Plus and Dexcom’s G7 and G7 15 Day CGMs.

Beta Bionics is also working to obtain an FDA green light for its updated 3D Intelligence dosing programs. In addition to the algorithm currently available with the company’s current iLet automated insulin pump, clinicians will be able to select an optimized version bolstered with the company’s real-world data, or a more conservative approach aimed at correcting high glucose levels.

Earlier this year, the company presented findings at the American Diabetes Association Scientific Sessions showing how real-world data led to a 25% improvement in users’ time within a healthy glucose range.

Pending the FDA’s clearance, Beta Bionics aims to deliver the iLet 3D and Mint 3D algorithms by the end of this year, with the latter in time for the patch pump’s full roll out.

“Delivering choice is critical to the community we serve, and that is what Mint 3D and iLet 3D are intended to offer: the choice of wearing a patch pump or tubed pump along with an algorithm experience that is uniquely suited to each individual, all with a particular focus on improving affordability through our efforts to expand access for both iLet and Mint in the pharmacy channel,” Beta Bionics President and CEO Sean Saint said in a statement.

In an update to the company’s financial guidance, Beta Bionics said it estimates a $10 million potential drop in 2026’s annual revenue compared to previous forecasts, as prospective iLet users may decide to wait for the Mint’s debut. Its predictions now land between $121 million and $126 million.

Beta Bionics’ CGM partnership with Senseonics

At the same time, the iLet will pick up a new CGM partner with the long-term, implantable Eversense 365 from Senseonics (NASDAQ: SENS). The two companies announced plans to integrate the two devices after completing validation and testing work scheduled through the end of this year.

“Building on the early success from our first pump integration, we believe the combination of year-long glucose sensing and advanced automated insulin delivery offers compelling, differentiated benefits for people with diabetes and expands the choices available to them within the AID category,” said Senseonics President and CEO Tim Goodnow.

Filed Under: Diabetes, Featured, Food & Drug Administration (FDA) Tagged With: Beta Bionics, Diabetes, FDA, Senseonics

IN CASE YOU MISSED IT

  • Beta Bionics insulin patch pump scores FDA clearance
  • Medtronic moves to divest final stake in MiniMed
  • Dexcom adds former Stryker CFO to board
  • MiniMed wins CE mark for next-gen insulin pump, ups revenue guidance
  • Abbott wins FDA authorization for dual glucose-ketone sensor

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