FDA 483 - Cardionxt - December 15, 2025

Cardionxt, a medical device manufacturer in Denver, CO, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish and follow procedures for corrective and preventive actions, complaint investigations, and control of non-conforming products, particularly concerning software crashes in its iMap System that impacted patients. Additionally, Cardionxt was found to be non-compliant with Unique Device Identification (UDI) requirements, including database registration and device labeling.