DreaMed Diabetes has gained FDA approval for MODI, a prescription app that uses CGM data to autonomously recommend insulin adjustments for adults with type 2 diabetes on injections, extending automation beyond pump users and potentially transforming insulin care.
DreaMed Diabetes has won U.S. Food and Drug Administration clearance for MODI, a prescription mobile application designed to recommend insulin dose changes directly to adults with type 2 diabetes who use injections. According to the company, the software uses continuous glucose monitoring data and insulin records to generate personalised adjustments without requiring a clinician to approve every change, a step it says could reduce one of the most time-consuming parts of insulin management.
The clearance is notable because it extends automated insulin optimisation beyond pump users to the far larger population treated with daily injections. DreaMed says the app is cleared for adults using long-acting basal insulin alone or in combination with rapid-acting mealtime insulin, covering both simple and more complex multiple daily injection regimens. The company claims this creates a new category in diabetes care by bringing algorithm-driven dose support to patients who have not typically benefited from the closed-loop systems more common in pump therapy.
The FDA’s decision comes under its 510(k) pathway, the agency’s route for devices that can show substantial equivalence to an existing product already legally on the market. In practical terms, that clearance allows DreaMed to market MODI as a regulated software-as-a-medical-device product in the United States. The agency has in recent years also warned consumers about unapproved products making diabetes treatment claims, underscoring the importance of formal review for tools that influence insulin dosing.
DreaMed traces its roots to research work at Schneider Children’s Medical Center, part of Clalit Health Services in Israel, and says it has built up a portfolio of insulin-optimisation software over more than a decade. The company says its endo.digital platform is aimed at clinicians, while MODI is intended to move personalised, CGM-informed recommendations directly to eligible patients. HIT Consultant reported that the application is named in memory of Modi, or Mordechai, Amir, after the company received his family’s blessing through the Next October initiative.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
