Pivot, a tubeless patch pump, consists of two parts, with a 3 mL reservoir and a disposable battery. It features smartphone connectivity for bolus and monitoring, plus electronic accuracy without tubes or constant wear.
The pump requires no battery recharging and has removability for showering, sports or discretion. Its quick bolus button enables insulin delivery without a separate controller.
San Diego-based Modular Medical targets “almost-pumpers” on multiple daily injections (MDI) with its insulin pump. It hopes to deliver an option for adults with type 1 or type 2 diabetes with hesitancy toward traditional pumps. The company believes Pivot offers simplicity, affordability and flexibility. It hopes to improve adoption and long-term outcomes while reducing costs.
By developing its patented insulin delivery technologies, the company hopes to improve access to glycemic control. Its founder, Paul DiPerna, previously founded leading insulin pump maker Tandem Diabetes Care. DiPerna invented and designed Tandem’s t:slim pump.
Modular Medical already has manufacturing readiness in place, announcing production validation lots in February. It said its initial capacity supports around 6,000 users with its scalable low-cost platform ahead of a rapid production ramp. The company expects to begin initial shipments by the end of the second quarter of 2026. It targets CE mark approval in the fourth quarter of 2026 or the first quarter of 2027.
The company also has software enhancements for variable bolus, improved alarms and ACE/AID compatibility under development.
Jeb Besser, CEO of Modular Medical, said:
“FDA clearance for Pivot represents years of focused innovation to deliver a truly differentiated tubeless patch pump. By addressing the key barriers – complexity, bulkiness, and high cost – we believe we are positioned to convert millions still on injections to pump therapy. With manufacturing on track and our software roadmap advancing toward automated insulin delivery (“AID”) features, we believe this clearance significantly de-risks our commercial launch and opens a clear path to capturing share in the growing diabetes technology market.
“We thank our team, stakeholders, and shareholders for their support. We now shift focus to our rapid commercialization strategy, additional software enhancements, and European CE Mark progress in the second half of 2026. We look forward to providing operational and adoption updates in the coming months.”
