Modular Medical shares surge 10.45% intraday after submitting Pivot tubeless insulin patch pump for FDA 510(k) clearance.

Modular Medical surged 10.45% intraday after announcing the FDA 510(k) premarket submission for its Pivot tubeless insulin patch pump, targeting the $3 billion "almost-pumper" market. The submission, delayed by the U.S. government shutdown, marks a critical regulatory milestone, with the company expecting initial FDA questions in Q4 2025 and a Q1 2026 commercial launch. The Pivot’s design—a 3 ml removable reservoir, detachable components for showering/activities, and bolus capability without a separate controller—positions it as a simplified, user-friendly alternative to existing insulin delivery systems. CEO Jeb Besser emphasized the product’s potential to improve patient adoption of pump therapy over injections, reduce healthcare costs, and enhance clinical outcomes. The news aligns with the stock’s intraday rally, driven by optimism over regulatory progress and market differentiation in a high-growth diabetes care segment.