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FDA Gives Rare Clearance to AI Tool That Flags Harder-to-Detect Heart Attacks on EKGs

The FDA has granted a rare "de novo" clearance to an AI model from Powerful Medical meant to help triage chest-pain patients by catching harder-to-detect heart attacks on an EKG.

Step by step

  1. 1

    Patient gets a 10-second EKG for chest pain

  2. 2

    AI model analyses the EKG in real time

  3. 3

    Tool flags ST-segment elevation, even subtle cases

  4. 4

    Patient triaged to a cardiac catheterisation lab

  5. 5

    Blockage opened, oxygen restored to the heart

A wave of AI algorithms has promised to help catch heart conditions earlier by analysing an electrocardiogram (EKG), the common 10-second test of the heart's electrical activity. AI tools have already been cleared to screen for common arrhythmias and structural heart conditions, and others in development aim to identify patients at the highest risk of sudden cardiac arrest.

Most of these tools focus on early diagnosis and prevention, but a newly cleared model aims to help during an actual heart attack. Last week, the U.S. Food and Drug Administration (FDA) issued a rare "de novo" classification to a model from Powerful Medical, intended to help triage patients to the right care when they are having chest pain. The vast majority of AI medical devices reach the market through the FDA's 510(k) clearance pathway; fewer than ten a year receive , which typically requires more clinical evidence.

The most severe kind of heart attack happens when a coronary artery supplying blood to the heart is completely blocked. Those patients need to reach a cardiac catheterisation lab as quickly as possible to reopen the blockage and restore oxygen to the heart. On an EKG, doctors identify this kind of heart attack from a characteristic pattern called "" — the sign the new tool is designed to help catch, including in harder-to-detect cases.

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#AI#heart attack#FDA#medtech#EKG
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