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RegulationSeptember 28, 2026

DreaMed Wins FDA Clearance for CGM-Driven Insulin Automation Tool for Both Type 2 Injection Regimens

DreaMed Diabetes obtained FDA 510(k) clearance for MODI, a mobile application that integrates continuous glucose monitoring data to generate insulin dosing recommendations for Type 2 diabetes patients on basal and fast-acting injection regimens. The clearance expands the tool's indication from prior single-injection use cases.

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