The rollout marks the start of real-world patient use of the Pivot pump. It marks San Diego-based Modular Medical’s transition to a commercial-stage medical device company.
Modular Medical designed Pivot to make insulin pump therapy simpler to learn and easier to live with. It features a removable, two-part design and a 3 mL reservoir, intuitive interface and flexible, wearable form factor. The system aims to support everyday activities, like showering and sports, with no battery charging required, all while maintaining clinical accuracy and connectivity.
Pivot won FDA 510(k) clearance in April. Modular Medical labels it the second fully electronic, tubeless insulin pump available in the U.S.
Modular Medical’s technology targets “almost-pumpers” on multiple daily injections (MDI). 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.
The company plans to roll out Pivot in phases, initially targeting select high-volume endocrinology practices. It expects to expand across multiple metropolitan markets by late 2026. Modular Medical also 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.
Commentary from Modular Medical leadership
Jeb Besser, CEO of Modular Medical, said:
“Reaching commercial availability is a transformational milestone that marks Modular Medical’s transition from a development-stage company to a revenue-generating commercial business. As only the second fully electronic tubeless pump on the U.S. market, Pivot is positioned to serve a large, underserved ‘almost-pumper’ population. With first shipments beginning this week, we are focused on disciplined execution, as we scale adoption and seek to build long-term value for patients and shareholders.”
