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Health & Life SciencesResearch paperSource analysis

Commercial clot-detection AI missed the cases that were easiest to overlook

Across more than 67,000 CT examinations, two FDA-cleared models were highly specific but less sensitive than their clearance studies suggested—especially for smaller, older and incidental clots.

By The Impact of AI Editorial Desk•Released 21 October 2026 at 14:58 BST•3 min full report · 1 min summary•2 sources · view evidence

The short version

What happened
The retrospective study evaluated 30,678 dedicated CT pulmonary angiograms and 37,191 routine contrast-enhanced CT examinations across 17 facilities from April 2023 to April 2025.
Who it affects
For a patient, the practical risk is false reassurance: the commercial system was least dependable for subtle or older clots. Radiologists still need to inspect the scan and clinical context even when the AI returns no alert.
What remains unproven
This was retrospective work in one academic health system, albeit across 17 facilities; community and rural performance may differ.

Keep in mind

This was retrospective work in one academic health system, albeit across 17 facilities; community and rural performance may differ.

The main reference labels came from radiology reports exposed to the AI output, not an independent blinded image-review panel.

Suboptimal and indeterminate examinations were excluded, and software-version differences make the FDA benchmark illustrative rather than like-for-like.

No causal patient outcome—such as time to treatment, complications or mortality—was measured.

Source analysis · 2 linked sources. Primary analysed source date: 21 October 2026. Earliest linked supporting source: 29 September 2026.

Read the full report · 3 min The evidence, methods, implications and limitations

High specificity hid a clinically important miss rate

Researchers at Emory evaluated two Aidoc algorithms already running in clinical practice. On 30,678 dedicated scans, the pulmonary-embolism model reached 86.8% sensitivity and 99.1% specificity. Its sensitivity was below the 94.9% reported in the FDA clearance summary, although the study populations and software versions may not have been identical.

The gap widened where help may be most valuable. Sensitivity declined from 99.3% for saddle emboli to 72.9% for subsegmental emboli, and from 89.7% for acute clots to 65.3% for non-acute ones. A negative flag therefore could not safely end a radiologist's search for a subtle clot.[1][2]

Incidental clots were a harder test

A separate algorithm examined 37,191 routine contrast-enhanced chest and abdominal CT studies, where pulmonary embolism was not the reason for scanning. It detected 336 of 457 confirmed incidental emboli: 73.5% sensitivity, alongside 99.8% specificity.

In a selected subset later given dedicated imaging, it had flagged 42 of 61 emboli confirmed on follow-up and missed 19. That supports using the tool as a second look, not an autonomous clearance step. The study did not measure whether any flag prevented harm or accelerated treatment.[2]

The distinction that matters

Where the algorithm's sensitivity fell

The same system was much more likely to flag a large central clot than a small peripheral or older one.

Saddle clot

Run the dedicated PE model

99.3% sensitivity

Subsegmental clot

Run the same model

72.9% sensitivity

Incidental clot

Run the routine-CT model

73.5% sensitivity

Sensitivity is the share of report-confirmed positive cases the model flagged. These categories differ in anatomy and scanning context, so they are not interchangeable severity estimates. Source: arXiv

The real-world label was not fully independent

The team extracted labels from final radiology reports with a validated language-model pipeline that achieved 97% accuracy and a kappa of 0.94 against expert labels. But clinicians could see the AI flag, so the reference standard may favour the deployed system. There was no blinded image re-adjudication of every discordant case.

The work was NIH-funded in part; Aidoc supplied aggregated prediction outputs but the authors say it had no role in design, analysis or writing. Prospective, independently adjudicated studies across unrelated health systems—and patient outcomes rather than detection metrics—would change the assessment most.[2]

Continue the story

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Explore the full source and evidence record

What this means for people

  • For a patient, the practical risk is false reassurance: the commercial system was least dependable for subtle or older clots. Radiologists still need to inspect the scan and clinical context even when the AI returns no alert.

Global context

Both algorithms were evaluated in a US health system under FDA-cleared use. Hospitals elsewhere may use different scanners, protocols, disease prevalence, reporting practices and regulatory versions; local post-deployment monitoring remains necessary.

What the evidence does not yet show

  • This was retrospective work in one academic health system, albeit across 17 facilities; community and rural performance may differ.
  • The main reference labels came from radiology reports exposed to the AI output, not an independent blinded image-review panel.
  • Suboptimal and indeterminate examinations were excluded, and software-version differences make the FDA benchmark illustrative rather than like-for-like.
  • No causal patient outcome—such as time to treatment, complications or mortality—was measured.

What to watch next

  • Prospective multi-system validation with independent blinded image adjudication
  • Performance on suboptimal scans and software-version-specific reporting
  • Whether alerts reduce diagnostic delay without creating unsafe reliance or alert fatigue
  • Patient outcomes and subgroup estimates with enough cases for narrow confidence intervals

Living evidence record

Impact record IAI-1COCBSE

Explore the full tracker

Evidence stage

Studied

Confidence

Supported

Reporting basis

Source analysis

Independent or research support

Present

Record status

Monitoring

Last checked

21 October 2026

Source trail

2 direct sources across 1 source type.

People impact

Documented in this record.

Uncertainty

Limits and next checks are explicit.

Stages describe the evidence available—not whether a technology is good or bad. See the public method.

Related-source reporting disclosure

This record analyses 2 linked source records around the same underlying development. The extra records add method, date or context, but they do not by themselves constitute independent replication of every performance claim or predicted outcome.

Evidence trail

Sources used for this report

Links checked 21 October 2026

1npj Digital Medicine• Research paper• 21 October 2026• United StatesMulti-site real-world performance of commercial AI for pulmonary and incidental pulmonary embolism detectionPeer-reviewed open-access article. The evaluation covers one US academic health system with 17 facilities and two algorithms from one commercial platform; it is not a comparison of vendors.2arXiv• Research paper• 29 September 2026• United StatesMulti-Site Real-World Performance of Commercial AI for Pulmonary and Incidental Pulmonary Embolism DetectionPublic author manuscript used to verify cohort construction, subgroup results, funding, conflicts and limitations. The peer-reviewed version appeared on 21 October 2026.
Research question, topics and regions

How two FDA-cleared pulmonary-embolism algorithms performed after deployment across a large academic health system

Topics: Medical imaging · Patient safety · Pulmonary embolism · Post-market surveillance · Commercial AI

Regions: United States

This report is labelled source analysis. We summarise and analyse source material in our own words; company statements remain attributed claims until independently supported. Translated summaries preserve the meaning of the original source and link back to it. Read our editorial standards.