DreaMed Diabetes has received FDA 510(K) clearance for MODI, a mobile app designed to help people with Type 2 diabetes manage insulin dosing. The app uses continuous glucose monitoring (CGM) data to generate insulin dosing recommendations for patients who require both basal and fast-acting injections.
This clearance expands DreaMed's presence in the Type 2 diabetes space, where automated insulin decision support has traditionally focused on Type 1 diabetes or simpler regimens. By addressing the combination of basal and fast-acting insulin, MODI targets a common but more complex treatment pattern.
The FDA's 510(K) pathway indicates that MODI was found to be substantially equivalent to an existing legally marketed device. The company has not yet disclosed a launch timeline or pricing details for the app.