FDA clears Israeli app that fine-tunes insulin doses for people with type 2 diabetes

In late September 2026 the US Food and Drug Administration granted 510(k) clearance to MODI, a prescription smartphone app from the Israeli company DreaMed Diabetes. The software reads data from a continuous glucose monitor together with a patient's insulin record and recommends how to change doses. It is cleared for adults with type 2 diabetes who inject long-acting insulin, with or without mealtime insulin, and once a physician prescribes it, the recommendations go straight to the patient's phone without a clinician having to set up the starting parameters or sign off on every change. Healio described it as the first insulin dosing app of its kind for this group.

The problem it targets is a familiar one. Continuous glucose monitors now record blood sugar around the clock, yet insulin doses are often reviewed only at clinic appointments months apart, and many patients never reach their targets. According to the company, about 85 percent of people who use insulin take it by injection rather than with a pump, more than eight million people in the United States alone, and most earlier automated tools served only a narrow subset of them. A 13-week study called MODIUS is under way to gather further evidence on safety, with time spent in dangerous low blood sugar as its main measure.

DreaMed was founded in 2014 to commercialise algorithms developed at the Institute for Endocrinology and Diabetes at Schneider Children's Medical Center in Petah Tikva, part of Clalit Health Services. The institute's head, paediatric endocrinologist Moshe Phillip, chairs the company, and Eran Atlas is co-founder and chief executive. The firm, which has about 30 employees, all in Israel, previously won FDA clearance for Advisor Pro, a decision-support tool that helps doctors adjust insulin pump settings for people with type 1 diabetes. Ynet reported that the new app is named after Mordechai 'Modi' Amir, a technology worker from Kibbutz Kfar Aza, with his family's consent.