Israeli Diabetes App MODI Secures FDA Approval for Type 2 Patients

Israeli startup DreaMed Diabetes has received FDA approval for its app, MODI, designed to assist Type 2 diabetes patients in managing their insulin therapy. The app analyzes blood sugar levels and insulin treatment data to provide personalized dosage adjustment recommendations directly to the user's mobile device, eliminating the need for individual doctor approval for each change.

MODI is the first solution of its kind to gain FDA approval under the 510(k) pathway for technology aimed at patients using either long-acting insulin or a combination of basal and rapid-acting insulin injections. This addresses a significant gap, as approximately 85% of insulin users, totaling over eight million people in the United States alone, rely on injections. Many struggle to maintain recommended blood sugar levels, with dosage adjustments often delayed until months-long intervals between doctor visits.

The app was developed to bridge this gap, offering a solution for adults with Type 2 diabetes who are prescribed insulin. It analyzes glucose patterns and treatment data to deliver tailored dosage recommendations between clinic visits. This functionality operates without requiring pre-set dosages by a physician or separate approval for each recommendation, thereby reducing the workload on healthcare professionals.

The app is named in memory of Mody (Mordechai) Amir, a 67-year-old tech professional who was killed on October 7. The connection between the Amir family and DreaMed was established through the Next October initiative, founded by Yizhar, Hila, and Ofir Shi in memory of their son and brother Yaron Shi, who fell in battle on October 7. The company chose to honor Mody by naming the app, which was registered under this name with the FDA.

Eran Atlas, co-founder and CEO of DreaMed Diabetes, stated that while continuous glucose monitoring is available, insulin treatment adjustments are often infrequent. He emphasized that MODI transforms data into timely, personal recommendations, bringing advanced diabetes technology benefits to millions of Type 2 patients using injections. Hila Shi, co-founder of Next October, added that their initiative focuses on building forward, with DreaMed's success carrying Amir's name and allowing his story to continue influencing the world, connecting memory, innovation, and hope.