DreaMed Diabetes Ltd., an Israeli diabetes software company, has received U.S. Food and Drug Administration 510(k) clearance for MODI, a prescription-only mobile application that recommends insulin dose adjustments directly to adults with type 2 diabetes who use insulin injections. The clearance was announced on September 28, 2026, and positions the company to expand automated insulin optimization beyond insulin pump users, who have been the primary focus of advanced diabetes technologies. The decision marks a notable step for personalized diabetes management in the United States.
Addressing a Persistent Gap in Insulin Care
Approximately 85% of insulin users rely on injections, representing more than eight million people in the United States alone. Many of these patients wait months between physician visits and struggle to achieve recommended blood glucose targets, leaving routine insulin adjustments delayed. Advanced insulin dosing technologies have largely focused on people with type 1 diabetes who use insulin pumps, which has created a significant gap for those with type 2 diabetes who rely on injections.
How MODI Works
MODI is indicated for adults aged 18 and older with type 2 diabetes who use long-acting insulin, with or without rapid-acting insulin. The app analyzes continuous glucose monitoring patterns and insulin therapy data to generate personalized dose recommendations between clinic visits. Unlike traditional insulin titration workflows, MODI does not require providers to configure initial settings or approve each recommendation individually, which may reduce routine clinical team involvement.
Regulatory Clearance and Market Impact
The 510(k) clearance opens a new category in insulin care by bringing automated insulin optimization to the 85% of insulin users who inject rather than use an insulin pump. In the United States alone, more than eight million people inject insulin, and many remain above recommended glucose targets for long periods. DreaMed expects the clearance to make insulin therapy more responsive between appointments while reducing the need for continuous clinical oversight.
A Tribute and a Clinical Milestone
The app is named in memory of Modi Amir, a technology professional from Kfar Aza who was killed on October 7. The connection with his family was made through the Next October memorial initiative, and the family consented to the name's use in the FDA registration. Eran Atlas, co-founder and CEO, said, "Data alone does not improve the health of patients; value is created when data is transformed into a timely, personalized recommendation patients can act on."
Company and Funding Background
DreaMed was founded in 2014 from technological initiatives at the Institute for Endocrinology and Diabetes at Schneider Children's Medical Center, part of the Clalit Group. The company employs 30 people in Israel and has raised a total of US$35.5 million since its founding, including US$12.5 million from investors and approximately US$23 million in non-dilutive funding. Its investors include Medtronic, eHV, SIBF, and OurCrowd.
The FDA clearance for MODI could expand access to automated insulin dosing guidance for millions of adults who inject insulin, a group that has long faced limited options. By removing the requirement for physician approval of each adjustment, the app aims to make routine insulin management more responsive between appointments and reduce the burden on clinical teams. DreaMed expects the decision to establish a new category in diabetes care and broaden the use of personalized decision support technology.