DreaMed Diabetes said today that U.S. FDA has granted a de novo request for DreaMed Advisor Pro, its AI-based diabetes treatment decision support software.

The news comes about four months after the Petah Tikva, Israel–based company won CE Mark clearance for the decision-support platform, which is meant to help healthcare professionals manage insulin therapy for people with Type I diabetes.

DreaMed Advisor Pro is a cloud-based software that provides insulin delivery recommendations. It analyzes information from CGM, self-monitoring blood glucose (SMBG), and insulin pump data. Through event-driven adaptive learning, Advisor Pro refines its understanding for each person it serves, providing recommendations to their healthcare provider about how to optimize insulin pump settings for basal rate, carbohydrate ratio (CR) and correction factor (CF).

“This is an innovation that can improve people’s lives, and the FDA decision confirms what we believe is an important step in making a more meaningful connection between the healthcare provider and their type 1 diabetes patients,” DreaMed CEO Eran Atlas said in a news release.

“Type I diabetes, managed with greater attention, leads to improved patient quality of life and reduced payer health-related costs. Advisor Pro enables patients using CGM and an insulin pump to analyze data and recommend to their provider when a change in diabetes-care treatment is timely and needed,” Atlas said.

DreaMed has a two-year-old deal with diabetes data management company Glooko to integrate Advisor Pro into the Glooko diabetes data management platform.