Modular Medical Receives FDA 510(k) Clearance for Next-Gen Tubeless Insulin Pump
Modular Medical announced U.S. Food and Drug Administration 510(k) clearance for its next-generation Pivot tubeless insulin patch pump. This milestone clears the path for commercial availability, with initial customer shipments planned by the end of Q2 2026. The Pivot is the first two-part tubeless patch pump featuring a removable 3 mL reservoir, disposable battery, smartphone connectivity for bolus and monitoring, and true electronic accuracy without tubes or constant wear. Designed specifically for "almost-pumpers" - adults with type 1 or type 2 diabetes hesitant about traditional pumps - Pivot offers simplicity, affordability, and flexibility to improve adoption and long-term outcomes while potentially reducing healthcare costs.
