Modular Medical, the company behind the MODD1 insulin pump, has received FDA 510(k) clearance for its new tubeless insulin patch pump, Pivot.

The tubeless pump is designed to make pump therapy more approachable for adults with type 1 and type 2 diabetes who currently use multiple daily injections (MDI). Modular Medical calls this market "almost-pumpers." The company notes that about 70% of insulin-dependent adults remain on MDI due to cost, complexity, and cumbersomeness, which is a core driver behind Pivot's design philosophy.

Pivot uses a two-part design with a removable 3 mL reservoir, a disposable battery, and smartphone connectivity. No battery recharging is required, and the pump can be removed for activities like showering. Pivot includes a dedicated bolus button for on-device dosing similar to those seen on the Tandem Mobi and twiist insulin pumps. It is worth noting that Pivot is not an automated insulin delivery (AID) system; it will function as a manual pump and not connect to a continuous glucose monitor (CGM).

Modular Medical is targeting an initial U.S. launch in Q2 2026, with software enhancements to follow. The company has moved past early testing and has initial production units available for approximately 6,000 users, with production rapidly ramping up. International expansion is also on the roadmap, with CE mark approval expected by late 2026 or early 2027.

While Omnipod currently holds the patch pump market largely to itself, the tubeless space is heating up. Beta Bionics, Tandem, and MiniMed are all developing competitors: the Mint, Tubeless Mobi & Sigi, and MiniMed Fit, respectively, making Pivot's timing even more relevant.

What do you think of the Pivot pump? Let us know in the comments.

Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a physician before making changes to your healthcare.