Modular Medical is moving closer to launch of its new Pivot insulin pump, announcing it has begun producing validation lots for the device. The validation lots include the disposable cartridge and infusion set for the next generation Pivot system, supporting plans to scale production once FDA approval is obtained.
Pivot is a tubeless insulin patch pump built around a full 3 mL removable cartridge and infusion set. Modular Medical says the user interface and overall experience are intended to be more approachable for people who may find current pump options overwhelming. Currently, the only patch pump on the market is Omnipod.
The pump is specifically targeted at adults with diabetes using multiple daily injections who have been reluctant to switch to pumps due to cost or usability concerns. By offering a simpler and more affordable option, the company believes Pivot could expand access to pump therapy and provide a meaningful upgrade for millions currently managing diabetes with injections.
Modular Medical submitted Pivot to the FDA through the 510(k) pathway on November 14, 2025 and remains on track for a commercial launch in the first quarter of 2026, pending clearance.
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