Modular Medical Secures FDA Clearance, National PBM Contract

8 sourcesUpdated Sep 4, 2026

Modular Medical secured a contract with a national U.S. pharmacy benefit manager, making its Pivot tubeless insulin patch pump available through the PBM and potentially expanding patient access. The company said the agreement represents an important commercialization milestone because PBMs help determine reimbursement and formulary access for medical technologies. Separately, the FDA cleared software enhancements for Pivot, including more flexible bolus dosing, customizable insulin delivery with each button press, an updated user interface and other upgrades. Modular Medical plans a phased commercial rollout in selected U.S. markets beginning in October 2026, with Inizio supporting commercialization and provider engagement.

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American Regent recalls epinephrine vials over glass, nylon particle contamination

American Regent is recalling three lots of Epinephrine Injection, USP 30 mg/30 mL (NDC 0517-3030-01) due to sterility concerns and the presence of particulate matter, including nylon, glass, acrylic, polyethylene, and cellulosic materials, with cracked and leaking vials found in nationwide distribution. The recall targets hospital and clinic multi-dose vials (not EpiPen auto-injectors) used for emergency treatment of severe allergic reactions and septic shock, and no adverse events have been reported yet; healthcare facilities should remove the recalled lots (25128L1C0, 25280L1C0, 26108L1C0) and can contact American Regent at 1-800-645-1706 for guidance.

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