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Medical Devices / Submissions and Approvals

DreaMed’s Insulin Dosing Software Earns Clearances

Sept. 18, 2019

DreaMed Diabetes has received both the CE Mark and the FDA’s 510(k) clearance for its Advisor Pro software for Type 1 diabetes patients.

The AI-based software is designed to optimize insulin administration for patients that use insulin pump therapy with continuous glucose sensors and/or blood glucose meters.

“This is the first decision support system that has been cleared to assist healthcare providers in the management of people with T1D who use insulin pumps or BGM,” said DreaMed CEO Eran Atlas.

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