
FDA Clears Beta Bionics’ Mint Reusable Insulin Patch Pump
The US FDA cleared a novel insulin patch pump that can be used for up to 3 days with an additional 12-hour grace period in persons with diabetes.
The US Food and Drug Administration (FDA) has cleared Mint™, a smartphone-controlled insulin patch pump for persons with
Beta Bionics also announced that it has submitted a separate 510(k) application for 3D Intelligence, its next-generation automated insulin dosing algorithm. If cleared, the algorithm is expected to power both the company’s tubed iLet pump and the new Mint patch pump under the names iLet 3D and Mint 3D, respectively.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,” Sean Saint, president and chief executive officer of Beta Bionics, said in a statement.¹ “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.”
Mint Combines Reusable and Disposable Components
Mint uses a 2-piece architecture consisting of reusable and disposable components. According to Beta Bionics, the system is smaller than the leading patch pump and is designed to allow patients to change the disposable patch without pairing the device with their smartphone again.¹
Features planned for the Mint 3D configuration include:
- A 200-unit insulin reservoir
- Up to 3 days of wear, followed by a 12-hour grace period
- Smartphone control through iOS and Android devices
- Compatibility with
Dexcom G7 ,Dexcom G7 15 Day , andFreeStyle Libre 3 Plus - Over-the-air firmware updates
- No recharging requirement
- An IPX8 waterproof rating at depths of up to 5 feet for 60 minutes
The company stated that the reusable-disposable design is also intended to limit environmental waste. Final specifications may change before commercialization, and the availability of Mint 3D remains contingent on FDA clearance of the 3D Intelligence algorithm.¹
3 Algorithm Options Planned for Clinicians
The investigational 3D Intelligence technology is designed to offer clinicians 3 selectable algorithm experiences based on an individual patient’s insulin requirements:
- Original: An experience based on the algorithm currently used with the iLet system, which has accumulated real-world experience in more than 40 000 users.
- Optimized: An enhanced version incorporating lessons from the company’s real-world experience with iLet.
- Conservative: An alternative designed to provide a more measured response when correcting high glucose levels.
The clinician-selected settings are intended to increase personalization while preserving the adaptive dosing and automation of the existing iLet platform. Beta Bionics’ current dosing technology autonomously calculates insulin doses using CGM data, reducing the need for conventional pump settings and manual dose calculations.
Subject to FDA clearance, Beta Bionics expects to commercialize iLet 3D by the end of 2026. Mint 3D is expected to become available alongside the full Mint launch during the first quarter of 2027.¹
Reference:
- Beta Bionics. Beta Bionics announces FDA clearance of Mint, the company’s transformative patch pump, and unveils 3D Intelligence as its next-generation insulin dosing algorithm. News release. September 14, 2026. Accessed September 15, 2026.
https://investors.betabionics.com/news-releases/news-release-details/beta-bionics-announces-fda-clearance-minttm-companys























































































































































