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BriefMEDTECH

Artificial Pancreas Closed-Loop Blood Glucose Management System PancreasAI Receives FDA Approval: Type 1 Diabetes Patients Say Goodbye to Manual Insulin Injections

Beta Bionics releases PancreasAI fully closed-loop artificial pancreas system. AI algorithms automatically regulate dual-hormone release of insulin and glucagon, improving time-in-range from 65% to 92% in clinical trials.

Beta Bionics announced on November 28 that the PancreasAI fully closed-loop system has received FDA approval. The system comprises three components: a continuous glucose monitoring sensor (reading every minute), an AI controller running predictive algorithms, and a dual-hormone insulin pump releasing both insulin and glucagon. Unlike previous single-hormone artificial pancreas systems, PancreasAI can release glucagon when blood sugar is about to drop too low, preventing hypoglycemic events at their root.

The Phase III trial enrolled 580 type 1 diabetes patients. Six-month follow-up showed the PancreasAI group achieved 92% time-in-range (70-180 mg/dL), compared to 65% for the traditional insulin pump control group. Hypoglycemic events were reduced by 87%. Patients needed no manual carbohydrate counting or insulin injection—the system managed everything autonomously.

The PancreasAI system is priced at $8,500 with monthly consumable costs of approximately $300. Medicare has included it in reimbursement coverage. Beta Bionics' CEO stated the company is developing a next-generation product integrating the glucose sensor and insulin pump into a single implantable micro-device.