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Modular Medical Pivot patch pump

Modular Medical

An FDA-cleared removable, two-part tubeless insulin patch pump aimed at adults who want a simpler, lower-friction pump. It has a 3 mL reservoir, smartphone connectivity and a quick bolus button, but no commercial AID integration yet.

On the horizonRegulator-approvedpumppatchtubelessphone-controlfda-clearedOfficial site ↗

The scorecard

Interoperability35

FDA clearance covers insulin delivery; no CGM or AID interoperability is established yet.[1]

Reliability55

FDA 510(k) clearance supports core delivery safety, but real-world reliability data are not yet published.[1]

Form factor85

Tubeless removable patch design with two-part wear, a 3 mL reservoir and no tubing is a strong form-factor improvement for many MDI users.[2]

Phone control70

Pivot includes smartphone connectivity for bolus and monitoring plus an on-device quick bolus button.[2]

Capacity78

3 mL reservoir is 300 units of U-100 insulin, larger than 200-unit pods.[1]

Access & cost35

FDA-cleared in 2026, but early deployment/commercial launch is still ramping and coverage is unknown.[2]

The full picture

Pivot is not trying to be the fanciest pump. Its stated target is the “almost-pumper”: adults who rely on injections because traditional pumps feel complex, expensive or cumbersome. The interesting design choices are simplicity, removability, 300-unit capacity and controller-light bolusing. The limitation is just as important: it is an insulin pump, not yet a closed-loop ecosystem.

Coming soon

ETA · FDA-cleared April 2026; initial patients and commercial launch expected in 2026

Sources

  1. [1]FDA 510(k) review: Modular Medical Pivot Insulin Delivery System (K253534) · regulatory · 2026-05-01
  2. [2]Modular Medical receives FDA 510(k) clearance for Pivot tubeless insulin patch pump · manufacturer · 2026-04-09
  3. [3]Modular Medical pump overview · manufacturer