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# FDA Panel Rejects AngelMed Guardian System
- URL: https://www.fdaweb.com/fda-panel-rejects-angelmed-guardian-system/
- Published: 2016-03-18T12:00:00.000Z
- Updated: 2026-09-15T02:45:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135135

> FDA’s Circulatory System Devices Panel has voted unanimously to not recommend approval of an AngelMed PMA for its Guardian System to warn about electrocardiogram elevation changes in the segment between the S wave and the T wave, which potentially is linked to coronary ischemia. Panel members cited protocol deviations and a missed primary efficacy endpoint, but said the device could be approved with additional data.  
>  
> The system comprises an implantable device, an external component, and a programmer. Once an ST shift is detected, the system is designed to alert patients to seek medical care by delivering a series of vibratory, auditory, and visual warnings.