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FDA Authorizes AI Tool for Detecting Mitral Annular Calcification on Routine CT

FDA Authorizes AI Tool for Detecting Mitral Annular Calcification on Routine CT

Bunkerhill Health receives FDA clearance for an AI model that detects mitral annular calcification (MAC) on routine, non-gated CT scans.

Key Details

  • 1Bunkerhill Health’s AI model (Bunkerhill MAC) is FDA-cleared to detect and evaluate MAC.
  • 2The tool works on routine, non-gated CT scans, expanding accessibility for cardiovascular risk detection.
  • 3This is the first FDA-approved AI specifically for MAC identification.
  • 4Development included data from over 25 academic medical centers, including Stanford University.
  • 5The algorithm is integrated into Carebricks, Bunkerhill Health’s generative AI platform.

Why It Matters

This clearance introduces a new, scalable AI solution to consistently identify a cardiovascular risk marker that can be missed in routine practice, potentially improving patient care and research. Automating MAC detection could significantly impact cardiovascular and structural heart disease assessments in radiology workflows.
Cardiovascular Business

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Cardiovascular Business

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