Cleerly vs Lunit

Published numbers on Lunit are mixed. A prospective study of 4,752 cases (Diagnostics, 2023) reported an AUC of 0.84 and specificity of 0.81, down from 0.94 in the retrospective work, with mostly clinically insignificant false positives. An independent 2025 PLOS Digital Health comparison found a newer INSIGHT CXR version less accurate for tuberculosis reading until its threshold was recalibrated. The chest X-ray FDA decision is for INSIGHT CXR Triage, while INSIGHT MMG and INSIGHT DBT are cleared as separate mammography and tomosynthesis products.

Lunit fits breast imaging centers with 2D and tomosynthesis screening volume and hospitals reading chest films. Cleerly sells to a coronary CTA program, a different exam from the chest and breast images Lunit reads. Its ISCHEMIA accuracy claims, including 868 invasive FFR measurements, are the vendor's. As of January 2026 Aetna, which requires an FDA-cleared platform, joined UnitedHealthcare, Cigna and Humana in covering Cleerly's analysis.