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Beta Bionics Mint (patch pump)

Beta Bionics

Pump and iOS/Android app cleared; commercial launch and 3D algorithm still pending.

What it is

Mint is Beta Bionics’ tubeless ACE patch pump, cleared by the FDA on 11 September 2026 (510(k) K260001) alongside the updated iLet Dosing Decision Software on iOS and Android (K262763). Full US commercialization is targeted for Q1 2027. The separate 3D Intelligence dosing algorithm remains under FDA review; proposed Mint 3D features 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

Full sources ↓Full discussion ↓Report an issue →

On the horizonRegulator-approvedpumppatchtubelessphone-controlOfficial site ↗

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: FDA 510(k) K260001 confirms bench and preclinical verification — including a 5.0 U occlusion-detection threshold, 4.5 mm 90-degree stainless-steel cannula, and 2-year expected controller life — ahead of Q1 2027 commercial rollout.[1]
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 ACE pump (K260001) and iOS/Android dosing software (K262763); 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: 64 × 20 + 60 × 20 + 88 × 20 + 88 × 15 + 58 × 10 = 6140; divide by total weight 85. Unrounded weighted result: 72.23529411764706. (Access & cost is excluded from the weighted score until commercial launch.)

Interoperability64

Mint has FDA ACE pump clearance (K260001) and pairs with the updated iLet Dosing Decision Software on iOS and Android (K262763), integrating with Dexcom G7, Dexcom G7 15-Day, and FreeStyle Libre 3 Plus. No DIY support is announced.[1]

Reliability60

FDA 510(k) K260001 confirms bench and preclinical verification — including a 5.0 U occlusion-detection threshold, 4.5 mm 90-degree stainless-steel cannula, and 2-year expected controller life — ahead of Q1 2027 commercial rollout.[1]

Form factor88

Fully tubeless two-piece patch pump with a reusable durable controller (expected service life 2 years; never needs recharging) and a single-use disposable cartridge containing the battery, 200-unit reservoir, pumping mechanism, and 4.5 mm 90-degree stainless-steel cannula, cleared under FDA K260001.[1]

Phone control88

FDA-cleared under K260001 and K262763 for full smartphone control via the iLet App on both iOS and Android — a major step up from the tubed iLet pump, whose companion app is view-only.[2]

Capacity58

FDA-cleared 200-unit maximum reservoir (20-unit minimum fill) with a cartridge wear duration of up to 3 days plus a 12-hour grace period, indicated for NovoLog and Kirsty U-100 insulin aspart — the same order as today's leading disposable pod, and below the 300-unit tubed pumps.[1]

Access & cost10

On the horizon — FDA-cleared (K260001 / K262763, September 2026) with full US launch targeted for Q1 2027 through pharmacies.[6]

Editor’s take

Mint brings Beta Bionics’ weight-initialized dosing approach into an FDA-cleared tubeless format (K260001 / K262763). The published 510(k) summaries confirm a two-piece reusable controller (2-year life, no charging) and 3-day + 12-hour disposable cartridge (200 U max, 20 U min, 4.5 mm steel cannula, NovoLog/Kirsty U-100) controlled from iOS and Android. The Q1 2027 launch remains a company target, and the proposed 3D Intelligence algorithm is under separate FDA review.

The full picture

Clearance and launch

The U.S. FDA cleared the Mint ACE Pump (K260001) and the updated iLet Dosing Decision Software (K262763) on 11 September 2026 (announced by Beta Bionics on 14 September 2026). Full US commercialization is targeted for Q1 2027 through the pharmacy channel, superseding the May 2026 target of the end of Q2 2027. This remains a launch forecast, not current commercial availability.126

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.6

FDA-cleared hardware and software specifications

Per the published FDA 510(k) summaries (K260001 and K262763), the Mint ACE Pump is cleared under 21 CFR 880.5730 (product code QFG) for subcutaneous insulin delivery in people aged 6 years and older requiring insulin:12

  • Two-piece modular patch architecture: A reusable durable Controller (expected service life of 2 years, never requires recharging) mates with a single-use disposable Cartridge that houses the battery, reservoir, pumping mechanism, and inserter/cannula.1
  • Reservoir, wear duration, and insulin compatibility: 200-unit maximum fill volume (20-unit minimum fill), cleared for wear up to 3 days (72 hours) plus a 12-hour grace period with NovoLog and Kirsty U-100 rapid-acting insulin aspart.1
  • Cannula and occlusion detection: 4.5 mm, 90-degree stainless-steel cannula with an occlusion detection threshold of 5.0 units of missed insulin.1
  • iOS and Android smartphone control (K262763): The pump has no on-body screen; it communicates over Bluetooth Low Energy with the iLet App on iOS and Android smartphones, which hosts the cleared iLet Dosing Decision Software (21 CFR 862.1356, product code QJI). New software features cleared in K262763 include individual meal-type reset (allowing a user or clinician to reset learned insulin dosing for Breakfast, Lunch, or Dinner independently without wiping all therapy history) and a streamlined single therapy-reset flow.2

Mint is not commercially available at this review. Pharmacy distribution is planned; projected coverage should not be read as an individual insurance entitlement. Reliability and access scores reflect pre-launch status pending independent post-market patch performance evidence.7

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. [1]
    FDA 510(k) Summary K260001 — Beta Bionics Mint ACE Pump (cleared 11 September 2026) · Regulatory decision · 2026-09-11 — Clears the Mint ACE Pump (21 CFR 880.5730, product code QFG) for ages 6+: two-piece reusable controller (2-year life) + single-use disposable cartridge (up to 3 days + 12-hour grace period, 200 U max / 20 U min fill, 4.5 mm 90-degree stainless-steel cannula, 5.0 U occlusion threshold, NovoLog and Kirsty U-100 insulin aspart), controlled via the iLet App on iOS and Android.

    U.S. Food & Drug Administration. 510(k) Summary K260001 — Beta Bionics Mint ACE Pump (cleared 11 September 2026; 21 CFR 880.5730, product code QFG; ages 6+; 200 U max / 20 U min reservoir; 3-day wear + 12-hour grace period; 2-year reusable controller; 4.5 mm 90-degree stainless-steel cannula; 5.0 U occlusion threshold; NovoLog and Kirsty U-100).

  2. [2]
    FDA 510(k) Summary K262763 — Beta Bionics iLet Dosing Decision Software (cleared 11 September 2026) · Regulatory decision · 2026-09-11 — Clears the updated iLet Dosing Decision Software (21 CFR 862.1356, product code QJI) to run on the iLet App for iOS and Android smartphones paired with the Mint ACE Pump, adding individual meal-type reset (Breakfast, Lunch, Dinner) and a single therapy-reset flow.

    U.S. Food & Drug Administration. 510(k) Summary K262763 — Beta Bionics iLet Dosing Decision Software (cleared 11 September 2026; 21 CFR 862.1356, product code QJI; ages 6+; runs on iLet App for iOS and Android smartphones paired with Mint ACE Pump; adds individual meal-type reset for Breakfast/Lunch/Dinner and single therapy reset).

  3. [3]
    Beta Bionics Updates Commercialization Timeline Expectations for Mint, its Patch Pump in Development · Manufacturer · 2026-05-21 — Earlier May 2026 company announcement before the September 2026 510(k) clearance.
  4. [4]
    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 May 2026 company announcement.
  5. [5]
    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.
  6. [6]
    Beta Bionics announces Mint clearance and separate 3D Intelligence submission · Manufacturer · 2026-09-14

    Beta Bionics, 14 September 2026.

  7. [7]