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# ‘Bionic Pancreas’ Cleared by FDA
- URL: https://www.fdaweb.com/bionic-pancreas-cleared-by-fda/
- Published: 2023-05-19T12:00:00.000Z
- Updated: 2026-09-14T18:33:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154499

FDA has cleared a Beta Bionics 510(k) for the iLet ACE Pump and the iLet Dosing Decision Software for treating Type 1 diabetes in patients aged six years and older. “These two devices, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), will form a new system called the iLet Bionic Pancreas,” an [agency release](https://www.fda.gov/news-events/press-announcements/fda-clears-new-insulin-pump-and-algorithm-based-software-support-enhanced-automatic-insulin-delivery?ref=fdaweb.com) says, adding that the automated insulin dosing system uses an algorithm to determine and activate insulin delivery.

The pump uses an “adaptive closed-loop algorithm” that only requires a user’s body weight to initiate, FDA says. It also “simplifies use at mealtime by replacing conventional carb counting with a new meal announcement feature,” it says. “With the new feature, users can estimate the amount of carbs in their meal as small, medium or large and the algorithm learns over time to respond to users’ individual insulin needs.” The device’s software also determines and commands an increase, decrease, maintenance or suspension of all basal insulin doses and determines and commands correction doses of insulin based on input from the iCGM.