The Israeli startup helping type 2 diabetes patients receives FDA approval

The Israeli startup DreaMed Diabetes has received FDA approval for its MODI application, which analyzes blood sugar levels and insulin treatment data to provide personalized dosage recommendations directly to the mobile phones of type 2 diabetes patients, without requiring a doctor's approval for each recommendation. This is the first solution to receive FDA clearance under the 510(k) pathway for this type of technology.

The Israeli startup DreaMed Diabetes has received approval from the U.S. Food and Drug Administration (FDA) for its MODI application, designed for type 2 diabetes patients. The app analyzes blood sugar levels and insulin treatment data to provide personalized dosage recommendations directly to the patient's mobile phone, without requiring a doctor's approval for each recommendation. This is the first solution to receive FDA clearance under the 510(k) pathway for this type of technology, intended for patients on long-acting insulin only as well as those combining basal and rapid insulin in multiple daily injections. About 85% of insulin users are currently treated with injections, with over eight million people in the United States alone. Many do not reach recommended blood sugar levels, and months may pass before the next doctor visit and insulin dose adjustment. The app is named after Modi (Mordechai) Amir.