The US Food and Drug Administration (FDA) has cleared Mint, the insulin patch pump developed by Beta Bionics, clearing the way for full US commercialization in the first quarter of 2027.1
Frequently Asked Questions
What is Mint approved for?
The FDA has cleared Mint, an insulin patch pump from Beta Bionics, ahead of a planned first-quarter 2027 commercial launch for people with diabetes who use insulin.
How does Mint work?
Mint is a two-piece reusable and disposable insulin patch pump controlled through a smartphone app, integrating with the Dexcom G7, Dexcom G7 15 Day, and Abbott FreeStyle Libre 3 Plus continuous glucose monitors.
What is 3D Intelligence?
3D Intelligence is Beta Bionics' next-generation insulin dosing algorithm, submitted to the FDA through a 510(k) application, offering three selectable dosing experiences intended to power future iLet 3D and Mint 3D systems.
Beta Bionics announced the clearance alongside 3D Intelligence, a next-generation insulin dosing algorithm submitted to the FDA through a 510(k) application. The company expects Mint 3D and iLet 3D, its next-generation automated insulin delivery (AID) platforms, to launch pending additional regulatory clearance.1
“We believe that our next-generation AID platform, consisting of Mint 3D and iLet 3D, will represent a transformational advancement for people living with diabetes, subject to regulatory clearance by the FDA,” Sean Saint, president and chief executive officer of Beta Bionics, said in a statement. “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.”1
Mint enters a patch pump market currently led by Insulet's Omnipod 5, with Tandem Diabetes Care and Medtronic's MiniMed division also pursuing tubeless entries. Beta Bionics has built its automated insulin delivery franchise around iLet, whose fully adaptive dosing algorithm has been used by more than 40,000 people with diabetes. Mint is designed to extend this experience to a patch form factor for people who prefer to avoid a tubed pump.1
Mint uses a 2-piece reusable and disposable architecture designed to be smaller than the industry-leading patch pump and never requires recharging. Each disposable patch is designed for 3 days of wear, with an additional 12-hour grace period, and holds a 200-unit insulin reservoir. The device carries an IPX8 waterproof rating for use ≤5 feet deep for 60 minutes.1
Beta Bionics designed the disposable patch change process to avoid phone re-pairing, and the pump receives firmware updates over the air. Mint is controlled through a smartphone app compatible with iOS and Android and integrates with the Dexcom G7, Dexcom G7 15 Day, and Abbott FreeStyle Libre 3 Plus continuous glucose monitors.1
Beta Bionics plans to begin full US commercial launch of Mint in the first quarter of 2027, ahead of its previous target. The company expects to manufacture at least 1.5 million disposable Mint units during 2027, with potential to exceed this figure through additional automation and staffing. Mint is set to launch exclusively through the pharmacy channel.1,2
3D Intelligence algorithm and next-generation AID platform
Beta Bionics submitted 3D Intelligence to the FDA through a 510(k) application as its next-generation insulin dosing algorithm. The algorithm is designed to power both iLet 3D and Mint 3D, the company's next-generation automated insulin delivery platforms, pending regulatory clearance. 3D Intelligence builds on real-world experience with iLet's current algorithm across more than 40,000 users.1
The algorithm includes 3 selectable experiences intended to let clinicians tailor dosing to individual patient needs. Original reflects the algorithm currently available with iLet, while Optimized incorporates real-world learnings to build on it. Conservative is designed to deliver a more measured response when correcting high glucose levels.1
Beta Bionics expects to commercialize iLet 3D in the United States by the end of 2026, pending FDA clearance. Mint 3D commercialization is expected to align with Mint's full launch in the first quarter of 2027, also subject to clearance.2
References
Whooley S. Beta Bionics earmarks Q2 2027 for Mint patch pump launch, shares details on new tech. Drug Delivery Business News. Published May 21, 2026. Accessed September 14, 2026. https://www.drugdeliverybusiness.com/beta-bionics-q2-2027-mint-launch/
