A New Era in AI-Enabled ECG Diagnosis
A New Era in AI-Enabled ECG Diagnosis
Source: FDA De Novo Authorization | September 3, 2026
• AI-ECG model authorized by FDA to detect STEMI and STEMI equivalents.
• JCS relevance: directly supports the concept behind our Smartphone Mobile STEMI Activation Project: EMS ECG →
AI support → Coordination Center → one-click Cath Lab activation → direct PCI transfer.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250044
