Optellum Virtual Nodule Clinic

What does the risk score rest on?

The 510(k) text describes an algorithm that "calculates a single value, the LCP-CNN score" using only imaging features from the CT, shown against a database of cases with known ground truth. The cleared scope is tracking, assessment and characterization of incidentally detected pulmonary nodules on lung CT. openFDA lists one Optellum 510(k), K202300, dated March 5, 2021. The vendor's timeline shows a zero-click version of the prediction AI as ready for clearance in 2024.

Optellum calls its offering "the world's only FDA-cleared and UKCA / CE-marked reimbursable radiomics AI solution for lung cancer diagnosis." It also markets Lung Cancer Prediction AI and a Patient Discovery AI module for prioritization.

Who sells it?

Optellum was founded in 2016 and runs offices in Oxford, England and Houston, Texas. Its Trust Centre lists ISO 13485:2016 and ISO/IEC 27001. The vendor says LCP AI is integrated with RapidAI's Rapid Enterprise platform and that SimonMed built it into its workflow.

What do the papers cover?

A 2020 Thorax paper (PMID 32139611) is an external validation of a CNN tool to predict malignancy in pulmonary nodules. A 2023 Chest paper (PMID 36087795) compares CNN assessment of solitary pulmonary nodules with PET-CT and dynamic contrast-enhanced CT. A 2023 JAMA Network Open paper (PMID 36929398) recalibrates a deep learning model for low-dose CT to inform screening intervals. Several papers on the tool are model papers from the developer, and developer affiliation is unknown for each of these three.

The vendor states more than 71% more interventional procedures and more than 50% shorter time to diagnosis, and labels the sources as in preparation or internal data.

What does reimbursement look like?

No public price, though payment facts exist. The reimbursement page lists CPT code 0721T for CT tissue characterization without concurrent CT and add-on code +0722T for use with concurrent CT, effective July 1, 2022, both in Category III. The Medicare hospital outpatient rate under APC 1508, status indicator S, is $650.50 for 2026 (national average, before deductibles). Physician payment is carrier-priced and commercial payment varies.

The verdict

A nodule clinic that wants scoring and tracking for incidental findings, and a billing route for them, is the match, with the 2026 Medicare outpatient rate of $650.50 as the one national figure attached.