U-Pump Achieves Major FDA Regulatory Milestone for Patch Insulin Pump

HOUSTON - April 3, 2025 - PRLog -- U-Pump is excited to announce a significant regulatory achievement in the development of its next-generation patch insulin pump. The U.S. Food and Drug Administration (FDA) has officially acknowledged our Pre-Submission (Q-Sub) under the 510(k) pathway for substantial equivalence. The submission has been assigned tracking number Q250943 and is now under formal review.

This Pre-Submission marks a critical step in our regulatory journey, offering early and valuable feedback from the FDA on key aspects such as:

• The suitability of our chosen predicate devices
• Scope of required non-clinical and potential clinical testing
• Expectations regarding cybersecurity, usability, and system integration

The review period typically spans 3–6 weeks. During this time, our team is preparing for a possible teleconference with FDA reviewers and finalizing testing protocols in line with ISO and FDA standards.

Recent Highlights from U-Pump's Development:

• MVP patch pump is fully assembled and ready for upcoming trials
• Virtual model successfully passed metrology evaluation
• Over 400 users signed up for early access
• Active discussions with clinical partners and venture capital funds
• Preparing for pilot production and early-stage trials in the U.S., Israel, and the EU

"This acknowledgment from the FDA is more than just a milestone — it's a strong signal of regulatory alignment and a validation of our technology and approach," said the U-Pump team. "It meaningfully reduces the risk ahead of our full 510(k) submission and helps accelerate our path to market."

We extend our thanks to all early believers, partners, and advisors. Stay tuned for further updates as we continue building a more accessible, intuitive solution for insulin therapy worldwide.

https://u-pump.com/