HeartFlow vs Lunit

HeartFlow analyses coronary CT angiograms. Lunit works on chest films, mammograms and tomosynthesis. A hospital cardiac CT program that wants fractional flow reserve and plaque measurements from the vendor's cloud takes HeartFlow, whose first FFRct clearance was a De Novo in 2014 and whose Plaque Analysis later cleared through 510(k). A breast imaging center or a chest-film service takes Lunit, which holds 510(k) clearances for INSIGHT CXR Triage, INSIGHT MMG and INSIGHT DBT. The listed chest X-ray clearance is for triage only. A prospective multicenter Lunit study of 4,752 cases (Diagnostics, 2023) reported AUC 0.84, against 0.94 retrospectively. On cost, HeartFlow's 10-K describes revenue as pay-per-use, so a cardiac lab pays by case, while a breast center gets a Lunit quote through a contact form.