Modular Medical Inc

Modular Medical, Inc. announced that the U.S. Food & Drug Administration has cleared a set of software enhancements to its Pivot tubeless insulin patch pump, ahead of the planned fourth-quarter launch. The enhancements include customizable bolus dosing, an improved user interface, and other software upgrades, marking the first in a series of platform improvements. CEO Jeb Besser said the clearance expands functionality and flexibility for users, allowing them to customize the amount of insulin delivered with each button push. The Pivot system is designed to offer a simple, wearable insulin delivery platform for people with diabetes, and the company aims to make advanced insulin delivery more accessible.

Modular Medical announced that the first patients have completed onboarding and are now actively using the Pivot tubeless insulin patch pump in real-world settings. The milestone marks the transition from development to active patient use and represents a significant step in the company's commercialization strategy. The company will now collect real-world utilization data and user feedback to support broader adoption and continued product deployment optimization. The Pivot pump recently became commercially available in the U.S. following FDA 510(k) clearance, and is described as the first two-part tubeless patch pump featuring a removable 3 mL reservoir, disposable battery, and smartphone connectivity.