Modular Medical completed a Stage 1 ISO 13485:2016 audit for its Pivot insulin‑delivery system, confirming compliance with EU MDR 2017/745. The audit was conducted by BSI, the company’s notified body and registrar.
The audit marks a key step toward CE Mark approval, expected in 2026. A Stage 2 audit is scheduled for the first half of 2026, followed by a CE technical documentation review later that year, after which Pivot could launch in European markets.
Pivot builds on the earlier MODD1 patch pump; MODD1 cartridge production finished in August 2025 as the company shifts focus to Pivot. Pivot is designed as the first tubeless, removable 3‑ml patch pump, aiming to broaden access for patients deterred by complexity or cost.
In the United States, Modular Medical plans to submit Pivot for FDA clearance in October 2025, with clearance anticipated in Q1 2026. The company also unveiled a gamified training module for Pivot at the ADCES 2025 conference in August 2025 to improve patient and provider education.
The company remains a development‑stage entity with no current revenue and ongoing losses, but strong liquidity and a low debt‑to‑equity ratio. The milestone is expected to enhance investor confidence and position Pivot for a global rollout.
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