FDA Approval for AI Enabled Diabetes Software

June 20, 2018  Source: MobiHealthNews 274

The Food and Drug Administration (FDA) has granted approval for a request made by DreaMed regarding their artificial intelligence-enabled diabetic software, which is exclusively meant for the providers, who are managing Type 1 diabetes patients.

Eran Atlas, the CEO of DreaMed said, “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; Type 1 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.”

The cloud-based DreaMed Advisor Pro is a diabetes device meant for quick treatment decision support by analyzing data from continuous glucose monitors, insulin pumps, and self-monitoring. This software has integrated a number of components into its recommendations, such as basal rate, carbohydrate ratio and correction factor. Even the dosage recommendations are directed towards the monitoring clinician, who can forward the same to a patient’s diabetes management device with just a click.  

Eran Atlas further added, “The fact that it was cleared by the FDA on a special de novo application [represents] the first time that you have an algorithm that can recommend insulin changes or dosing based on CGM data; That was basically the main reason why the FDA wanted that to be a de novo application rather than a routine 510(k).” 

By Ddu