Optellum Virtual Nodule Clinic
Optellum
Produces a calibrated malignancy risk score for indeterminate pulmonary nodules on CT, intended to support decisions about surveillance intervals versus biopsy.
At A Glance
- Manufacturer
- Optellum
- Medical specialty
- Radiology
- Clearance route
- 510(k)
- Year authorized
- 2021
- Modality
- CT
- Role in workflow
- Clinical decision support
This is a different category from detection. The nodule has already been found. The clinical problem is what to do about it, and that problem is dominated by overtreatment of benign nodules and delayed action on malignant ones. A calibrated risk score attacks the decision rather than the perception.
Risk stratification tools are also easier to reason about clinically, because the output is a number on a scale the clinician already uses rather than a mark on an image.
Where It Is Used
- Incidental pulmonary nodule management
- Lung cancer screening follow-up decisions
- Multidisciplinary nodule board support
Limitations Worth Knowing
Calibration is population-dependent. A score validated on a screening cohort behaves differently in an incidental-finding population with different pretest probability. The device supports a decision and does not make one, and its score does not replace tissue where tissue is indicated.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.