Beta Bionics Mint (patch pump)
Beta Bionics
Pump cleared; commercial launch and next-generation algorithm still pending.
What it is
Mint is Beta Bionics’ tubeless patch pump, with FDA clearance announced on 14 September 2026. Full US commercialization is targeted for Q1 2027. The separate 3D Intelligence dosing algorithm remains under FDA review; proposed Mint 3D features and launch depend on that clearance.
Editorial review: .
Most recent recorded citation date: 2026-09-14. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.
- Benefit or performance
- Reliability: Pump clearance is announced, but a commercial patch-pump track record has not been established. iLet algorithm evidence cannot establish Mint hardware reliability. Score retained as an editorial estimate pending real-world evidence. Editorial estimate on this page.[4]
- Important harms and treatment burden
- Read the safety discussion and original sources. A missing summary does not establish safety.
- Approval and country access
- FDA-cleared pump; not yet commercially available. US launch targeted Q1 2027; Mint 3D depends on separate algorithm clearance.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Read the full discussion and original sources for follow-up duration and study limitations.
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 48 × 20 + 45 × 20 + 88 × 20 + 86 × 15 + 58 × 10 + 10 × 15 = 5640; divide by total weight 100. Unrounded weighted result: 56.4.
Mint has pump clearance. The proposed Mint 3D system names Dexcom G7, G7 15 Day and Libre 3 Plus, with iOS and Android control; its separate algorithm application remains under FDA review. No DIY support is announced. Pump clearance was announced 14 September 2026 per the manufacturer release cited; the algorithm application is separate.[4]
Pump clearance is announced, but a commercial patch-pump track record has not been established. iLet algorithm evidence cannot establish Mint hardware reliability. Score retained as an editorial estimate pending real-world evidence. Editorial estimate on this page.[4]
Fully tubeless, waterproof (showering and swimming) and never needs recharging. The two-piece reusable-plus-disposable architecture is explicitly designed to cut waste versus a fully disposable pod — though size, weight and on-body profile have not been published. Manufacturer specifications from the 21 May 2026 announcement cited; performance not independently verified.[2]
Full smartphone control on both iOS and Android is planned from launch — a large step up from the iLet, whose companion app is view-only. Planned features per the May 2026 manufacturer announcement cited.[2]
A 200-unit reservoir with about three days of wear plus a 12-hour grace period — the same order as today's leading disposable pod, and well below the 300-unit pumps. Per manufacturer specifications cited; the cross-product comparison is framing on this page.[2]
Full US launch is targeted for Q1 2027 through pharmacies. Mint is not yet commercially available; projected insurance coverage is not current access. Company target; availability status at this review.[4]
Editor’s take
Mint could bring Beta Bionics’ approach to dosing into a tubeless format. Pump clearance is a concrete advance. The Q1 2027 launch remains a company target, and the proposed 3D algorithm has not yet been cleared. Existing iLet outcomes do not establish the new patch’s reliability.
The full picture
Clearance and launch
Beta Bionics announced FDA clearance of the Mint pump on 14 September 2026. Full US commercialization is now targeted for Q1 2027, superseding the May target of the end of Q2. This is a launch forecast, not current availability.4
The separate 3D Intelligence algorithm remains under FDA review. Proposed iLet 3D and Mint 3D systems depend on that clearance. The manufacturer describes three clinician-selectable algorithm experiences; their clinical advantage over existing iLet therapy has not been established here.4
Proposed hardware
Earlier company specifications describe a reusable and disposable patch, 200-unit reservoir, three days of wear plus a 12-hour grace period, and no recharging. Smartphone control and the announced CGM combinations are planned system features. A launch specification does not substitute for the final authorized compatibility list.5
Mint is not commercially available at this review. Pharmacy distribution is planned; projected coverage should not be read as an individual insurance entitlement. Scores remain editorial estimates, with no independent post-market patch performance evidence established in this review.
Coming soon
ETA · Full US commercialization targeted Q1 2027; 3D Intelligence clearance pending
- →FDA decision on 3D Intelligence algorithm · Pending; iLet 3D targeted by end of 2026, subject to clearance
- →Full US Mint commercialization · Q1 2027 company target
Sources
- [1]Beta Bionics Updates Commercialization Timeline Expectations for Mint, its Patch Pump in Development · Manufacturer · 2026-05-21 — Company announcement (also filed as an exhibit to an SEC 8-K). Mint is "not available for sale"; its alternate-controller-enabled (ACE) pump 510(k) is under FDA review. Full commercialization is expected by the end of Q2 2027 "subject to regulatory clearance by the FDA", with the timeline based on the FDA's initial responses to that application.
- [2]Beta Bionics targets Mint patch pump launch by Q2 2027 — full device specs from the 21 May 2026 company announcement · Science journalism · 2026-05-21 — Wire carry of the same company announcement; source of the device specs quoted here (two-piece reusable/disposable architecture, 200-unit reservoir, three days of wear plus a 12-hour grace period, iOS and Android control, never requires recharging, waterproof, iAGC with Dexcom G7 / Dexcom G7 15 Day / FreeStyle Libre 3 Plus, pharmacy-channel distribution). Manufacturer claims, not independently verified performance.
- [3]The biggest diabetes tech news out of ADA 2026 · Science journalism — Trade-press round-up naming Mint among the next-generation pumps in development, with launch expected in 2027.
- [4]Beta Bionics announces Mint clearance and separate 3D Intelligence submission · Manufacturer · 2026-09-14
Beta Bionics, 14 September 2026.
- [5]