LungAI

An AI second opinion on every lung screening CT.

LungAI estimates the cancer risk of each detected lung nodule on low-dose CT, factoring in its change since the prior scan. Radiologists see a malignancy risk score for each nodule natively inside the PACS and CADe software they already use.

0.96Nodule-level AUROC, retrospective held-out NLST
0 to 100Malignancy score for each nodule
Prior scanComparison built into every score
LungAI
Illustrative example. NLST research case. LungAI is investigational, not FDA cleared.
LungAI is an investigational medical device and has not been cleared by FDA. Oatmeal Health is preparing a 510(k) premarket notification for submission to FDA. LungAI is not commercially available in the United States. Clinical performance data reflect retrospective studies on held-out datasets; results may differ in prospective use.

No new systems for your radiologists.

  • No new workstation.

    Scores appear inside the CADe or PACS viewer your radiologists already read in.

  • No new login.

    Nothing extra for radiologists to open, learn, or sign in to.

  • No IT project.

    Runs on your servers or our HIPAA-compliant cloud, with one PDF report per exam sent to PACS.

Beyond Lung-RADS categories

Limitations of categorical scoring

Lung-RADS is the foundation of lung cancer screening. Published literature highlights areas where categorical scoring alone leaves room for additional quantitative context.

Missed cancers

Cancers diagnosed after a negative screen

Some cancers diagnosed within screening programs were not flagged on the initial LDCT. Borderline nodules in Lung-RADS 2 and 3 are where the clinical uncertainty is highest.

~15%
False-negative rate in some programs
Bartlett et al., J Thorac Oncol 2021
False positives

36% of patients get a false alarm

More than one in three screened patients receive an abnormal result that turns out not to be cancer. Each false positive triggers unnecessary follow-up imaging, biopsies, and patient anxiety.

36%
False-positive rate (NLST substudy)
Gareen et al., Cancer 2014
Reader variability

29% category disagreement

Two radiologists reading the same scan assign different Lung-RADS categories nearly a third of the time. The patient's follow-up pathway depends on which radiologist reads the scan.

29%
Disagreement between readers
van Riel et al., Eur Radiol 2019

How LungAI works

A continuous score, inside the read you already do

Lung-RADS sorts nodules into a few categories. LungAI adds a probability to each one, so two nodules in the same category no longer look the same.

Nodule found by CADe

Step 1 · Nodule selected

Your CADe or radiologist finds the nodule

Detection stays with the tools you already use. LungAI starts from the nodules your CADe or reading physician has selected, with their size, volume, and density.

Step 2 · CADx scoring

LungAI scores each nodule, 0 to 100

The model reads the nodule, the context of the whole scan, the change since the prior exam, and basic patient history, then returns a malignancy score.

Step 3 · Report in PACS

The radiologist decides

A PDF report with the nodule image, the score, and a probability key is delivered into PACS alongside Lung-RADS. LungAI is decision support. It does not replace the read or recommend treatment.

What LungAI looks at

More than size and shape

Radiologists weigh far more than a diameter when they judge a nodule. LungAI is built to weigh the same things.

The nodule

Morphology such as margins, spiculation, and internal structure, not just diameter.

The whole scan

Context around the nodule, including lung tissue patterns such as emphysema.

The prior scan

When a prior LDCT exists, change in size, density, and shape over time feeds the score.

The patient

Age, sex, and smoking history, the same risk factors behind screening eligibility.

Validation

0.96 AUROC on held-out NLST data

LungAI was evaluated retrospectively on a held-out subset of the National Lung Screening Trial, with pathology-confirmed outcomes, at the nodule level. Clinical studies with Mass General Brigham and IQVIA are underway.

0.96 Nodule-level AUROC, retrospective held-out NLST dataset. LungAI is investigational and not FDA 510(k) cleared.
Retrospective case examples

Where a continuous score changes the conversation

Four held-out NLST cases illustrating how a continuous malignancy probability differs from categorical Lung-RADS scoring. Retrospective research examples only.

Lung-RADS 2 LungAI: 31.7
Confirmed malignant

Case 1: Elevated score on a Lung-RADS 2 nodule

Categorized Lung-RADS 2 (benign appearance, annual follow-up). In retrospective analysis, LungAI assigned a malignancy score of 31.7. Later confirmed malignant.

Size
10.9mm
Volume
619mm³
LungAI
31.7
Lung-RADS 3 LungAI: 77.1
Confirmed malignant

Case 2: High score on a Lung-RADS 3 nodule

Categorized Lung-RADS 3 (probably benign, six month follow-up). In retrospective analysis, LungAI assigned a malignancy score of 77.1. Later confirmed malignant.

Size
12.4mm
Volume
998.3mm³
LungAI
77.1
Lung-RADS 4A LungAI: 98.7
Confirmed malignant

Case 3: Very high score on a Lung-RADS 4A nodule

Categorized Lung-RADS 4A (suspicious). LungAI assigned a score of 98.7. Compare to Case 4, categorized 4A but assigned 0.3. The continuous scores differentiate nodules that categorical scoring treats similarly.

Size
13.0mm
Volume
1,150.3mm³
LungAI
98.7
Lung-RADS 4A LungAI: 0.3
Confirmed benign

Case 4: Low score on a Lung-RADS 4A nodule

Categorized Lung-RADS 4A (suspicious). In retrospective analysis, LungAI assigned a malignancy score of 0.3. Later confirmed benign.

Size
11.2mm
Volume
352.4mm³
LungAI
0.3

In this retrospective NLST sample, LungAI assigned higher probabilities to nodules later confirmed malignant and a low probability to a nodule later confirmed benign. Retrospective research only; prospective performance has not been established. All cases from a held-out subset of NLST. LungAI is not FDA cleared and is not available for clinical use.

Integration

Vendor-agnostic by design

LungAI is one scoring model that fits around the detection software, viewers, and scanners you already run.

CADe agnostic

Designed to accept nodule findings from any FDA-cleared CADe device.

Viewer agnostic

Scores appear in the CADe or PACS viewer radiologists already use. Coreline Soft's AVIEW is our launch CADe partner.

Scanner agnostic

Compatible with LDCT from GE, Philips, and Siemens scanners.

Deploy your way

Run LungAI on your own servers or in Oatmeal Health's HIPAA-compliant cloud.

PDF report to PACS

One report per exam, with the nodule image, score, and probability key.

Alongside Lung-RADS

The score adds context to the Lung-RADS category. The radiologist still makes the call.

Lung nodule CADx has an established reimbursement pathway, CPT 0721T, for use following FDA clearance. LungAI is investigational and not FDA 510(k) cleared. Read about reimbursement.

Get started

See LungAI in your viewer

A 30-minute demo of how scores appear in your CADe viewer and how the report reaches PACS.

LungAI is investigational and not FDA 510(k) cleared, and is not commercially available in the United States. Performance figures are from internal retrospective validation on held-out NLST data.