Modular Medical Achieves Key Manufacturing Milestone for Pivot Tubeless Insulin Patch Pump

Targeting Q1 2026 Launch, Subject to FDA Clearance

Published on Feb. 5, 2026

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Modular Medical, Inc., an innovative insulin delivery technology company, has announced the start of production of validation lots for its Pivot tubeless patch pump's disposable cartridge and infusion set. This critical manufacturing milestone keeps the company on schedule for a commercial launch of the Pivot system in Q1 2026, subject to receiving FDA 510(k) clearance.

Why it matters

The Pivot system, the industry's first removable, tubeless 3ml patch pump, is designed to be simple and affordable, addressing barriers that prevent many patients from adopting traditional insulin pumps. This could help transform access to insulin pump therapy, targeting the millions of adults relying on multiple daily injections who avoid pumps due to high cost and complexity.

The details

Modular Medical's scalable, low-cost manufacturing platform positions the company to capture significant share in the rapidly expanding diabetes tech sector. The start of production of validation lots confirms the company's readiness for high-volume demand, further derisking the expected path to Q1 2026 commercialization, which is subject to FDA response to Modular Medical's current 510(k) application.

  • Modular Medical announced the start of production of validation lots on February 4, 2026.
  • The company is targeting a Q1 2026 launch for the Pivot system, subject to FDA clearance.

The players

Modular Medical, Inc.

An innovative insulin delivery technology company that is developing the Pivot tubeless insulin patch pump.

Jeb Besser

The CEO of Modular Medical, Inc.

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What they’re saying

“We are excited to hit this pivotal manufacturing validation on schedule, bringing us closer to delivering our Pivot pump's game-changing simplicity to patients underserved by current options.”

— Jeb Besser, CEO of Modular Medical, Inc.

What’s next

Modular Medical's 510(k) application for the Pivot system is currently under review by the FDA. The company expects to receive FDA clearance and launch the Pivot system in Q1 2026, subject to the FDA's response.

The takeaway

Modular Medical's achievement of this key manufacturing milestone for the Pivot tubeless insulin patch pump significantly reduces execution risk for its commercial strategy, enhancing scalability and reliability ahead of the expected Q1 2026 launch. This differentiated, patient-centric product could help transform access to insulin pump therapy and disrupt the rapidly expanding diabetes tech sector.