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Health Tech January 03, 2026 2 min read

FDA Clears AI Tool That Reads Cardiac Scans in 90 Seconds

A newly cleared AI tool analyses cardiac MRI scans in under 90 seconds — compared to roughly 30 minutes for a specialist — and flags abnormalities for review.

Source: MedTech Dive

#fda #ai #medical #cardiac #imaging

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What happened

The U.S. Food and Drug Administration (FDA) cleared a new AI-powered tool designed to analyse cardiac MRI scans. The system processes a scan in under 90 seconds and highlights potential abnormalities for a specialist to review.

Why it matters

Cardiologists currently take around 30 minutes to manually review a single cardiac MRI. This tool does not replace specialists. It allows hospitals to triage urgent cases faster and reduce growing scan backlogs, particularly in under-resourced facilities.

Key numbers

  • 90 seconds per scan (vs. ~30 minutes manually)
  • 94% accuracy rate on the validation dataset
  • Cleared for adults aged 18 and over
  • Currently piloted in 12 hospitals across the U.S.

What to watch next

The tool is being expanded into emergency departments and rural clinics later in 2026. Similar AI imaging tools for lung and brain scans are also in the FDA review pipeline.

Source

MedTech Dive