Israeli App MODI Receives FDA Clearance for Insulin Dose Adjustments

Israeli startup DreaMed Diabetes has received clearance from the U.S. Food and Drug Administration (FDA) for its app, MODI. The application analyzes blood sugar levels and insulin treatment data to provide personalized recommendations for adjusting insulin dosage directly to the mobile devices of Type 2 diabetes patients who use insulin injections. This allows for dosage adjustments without requiring a doctor's approval for each recommendation.

Approximately 85% of insulin users, totaling over eight million people in the U.S. alone, rely on injections. Many struggle to maintain recommended blood sugar levels, with adjustments often delayed until months later during doctor visits. While advanced insulin dosing technologies have primarily served Type 1 diabetes patients using insulin pumps, options for injection users have remained limited.

The MODI app, prescribed for adults with Type 2 diabetes, analyzes glucose patterns and treatment data to offer personalized dosage guidance between clinic visits. This aims to reduce the burden on healthcare teams by enabling timely, data-driven adjustments. The app is named in memory of Mordechai (Modi) Amir, a technology professional who was killed on October 7. The connection was made through the Next October memorial initiative.

Eran Atlas, co-founder and CEO of DreaMed Diabetes, stated, "MODI enables millions of people with Type 2 diabetes to receive data-based guidance even between doctor visits, bringing the benefits of advanced diabetes technology to insulin injection users." DreaMed, founded in 2014 and based in Kfar Saba, Israel, has raised $35.5 million to date. Notable investors include Medtronic and OurCrowd.