Modular Medical shares surge 11.64% after hours after submitting FDA 510(k) for Pivot pump targeting $3B market.

Modular Medical surged 11.64% in after-hours trading following its announcement that it submitted its Pivot tubeless insulin patch pump for FDA 510(k) clearance, targeting a $3 billion market. The company highlighted the product’s removable reservoir, detachable design for patient convenience, and potential to improve diabetes care by reducing reliance on daily injections. The submission, delayed by the U.S. government shutdown, marks a critical regulatory milestone, with commercial launch planned for Q1 2026 upon clearance. CEO Jeb Besser emphasized the device’s simplicity and scalability, positioning it to address unmet needs in the diabetes market. The news reinforced investor confidence in Modular Medical’s ability to execute its commercialization strategy, aligning with the stock’s sharp post-announcement rally.