FDA Clears AI-Based Type 2 Diabetes Clinical Decision Support System

In October, DreaMed Diabetes AI LTD. announced that it received its fourth U.S. Food and Drug Administration (FDA) clearance for its Advisor Pro AI Clinical Decision Support System, which expands the platform’s target population to patients with both type 1 and type 2 diabetes.

Advisor Pro is a decision support system cleared to assist healthcare providers in the management of diabetes patients who use insulin pumps or injections and monitor their glucose using continuous glucose monitor and/or blood glucose meters.

The system leverages the power of artificial intelligence to optimize insulin administration. Advisor Pro aims to empower primary care clinicians, such as PCPs and NPs, to provide expert level endocrinological care to diabetes patients.

DreaMed Advisor Pro previously received a CE Mark and was cleared by the FDA for people with type 1 diabetes using insulin pump therapy with continuous glucose sensors and/or blood glucose meters and is already deployed by leading diabetes treatment centers, including Yale New Haven Health, Texas Children’s Hospital, the University of Florida, and more.

“Chronic diseases require constant care by experts,” says Moshe Phillip, MD, DreaMed’s chief science officer and the director of the Endocrinology and Diabetes Institute at Schneider Children’s Medical Center in Israel. “DreaMed has done significant clinical research to achieve a strong AI-based clinical decision support system that has just received the necessary FDA clearance. DreaMed Advisor Pro greatly expands the access to the much-needed expert-level care to millions of people. We are proud of this achievement and committed to work hard on its expansion to additional capabilities and treatment methods.”

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