Tech Talk: Israeli firm wins landmark FDA clearance for injection-based diabetes app

For decades, the standard of care for millions of people living with type 2 diabetes has operated under a fundamental paradox. While continuous glucose monitoring (CGM) technology has made real-time health data abundant, actual treatment adjustments remain slow and periodic.

Most patients using insulin injections still experience gaps between clinical appointments. During these intervals, their insulin dosages remain static, leaving a vast majority struggling to consistently hit their target glucose levels. As the healthtech sector has learned,  data is only as valuable as the actionable guidance it produces.

Now, Israeli startup DreaMed Diabetes is bridging that gap by creating a new standard for type 2 diabetes’ automated care, with a story deeply rooted in our country’s resilience.

Closing the 85% gap

Petah Tikva-based DreaMed Diabetes has just received FDA 510(k) clearance for MODI, a prescription medical application that automatically optimizes insulin dosing for adults with type 2 diabetes using injections. MODI delivers personalized recommendations to the patient's smartphone without requiring a physician to configure initial settings or approve every individual adjustment.

While automated insulin dosing has historically focused on type 1 diabetes patients using high-end insulin pumps, MODI marks the first FDA-cleared technology designed to bring continuous, algorithmic dose adjustment to injection users, spanning both basal-only and multiple daily injection (MDI) regimens.

This unlocks scalable support for the 85% of insulin users in the US alone who rely on injections rather than pumps. In the United States alone, over eight million people inject insulin daily.

"Today we can track glucose continuously, but insulin treatment is still only adjusted months apart," said Eran Atlas, Co-founder and CEO of DreaMed Diabetes. "Value is created when data is transformed into a timely, personalized recommendation patients can act on. MODI brings the benefits of advanced diabetes technology to millions who inject."

Innovation born of memory 

Beyond its technological and regulatory impact, MODI carries a profound personal legacy.

The app was named in memory of Modi (Mordechai) Amir z"l, a 67-year-old technology enthusiast and resident of Kibbutz Kfar Aza who was killed during the October 7 terrorist attacks.

The connection between the Amir family and DreaMed was fostered through Next October, an initiative founded by Izhar, Hila, and Ofir Shay in memory of their son and brother Yaron Shay z"l, who fell defending Kibbutz Kerem Shalom on October 7. Next October, pairs Israeli startups with fallen heroes, ensuring that every soul lost is memorialized through innovation that builds a better future.

With the blessing of the Amir family, DreaMed officially submitted and registered the application under Modi’s name with the FDA, weaving his legacy directly into global medical technology.

"Throughout DreaMed's history, we have always tackled complex, unsolved challenges," reflected Atlas. "We succeeded through creativity, persistence, patience, and determination. That was who Modi was, and it is a true honor for us to commemorate him in this way."

Hila Shay, Co-founder of Next October, emphasized the message of hope behind the collaboration: "At Next October, we believe that remembrance is not just looking back, but also building forward. DreaMed’s success carries Modi’s name and allows his story to continue impacting the world. They sought to destroy; we chose to build a better world."