[REVISION HISTORY]
FDA clearance of cardiovascular AI imaging tools
Updated 1 time since CLSTR started tracking revisions of this situation.
What changed
2026-10-24 23:34 UTC → 2026-10-25 10:45 UTC ·
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The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to new artificial intelligence-based software solutions for cardiovascular assessment. Coreline Soft received clearance for ‘AVIEW Aorta Metrics,’ an automated aortic analysis solution. The software utilizes chest CT images to automatically segment the aorta and provide quantitative measurements of anatomical diameters. This marks the company’s 13th FDA clearance, expanding its technological reach from pulmonary diseases into the cardiovascular domain. Additionally, Elucid received FDA clearance for FFR-IQ, a software designed for the noninvasive estimation of fractional flow reserve from coronary CT angiography (FFR-CT). The tool incorporates coronary anatomy and plaque composition to assist physicians in identifying patients who may require revascularization, potentially reducing the need for invasive catheterizations. In the ELUCIDATE FFR-CT study, the software demonstrated a sensitivity of 92.2% and a specificity of 93.1%.
Versions
- 2026-10-25 10:45 UTC FDA clearance of cardiovascular AI imaging tools
- 2026-10-24 23:34 UTC FDA clearance of cardiovascular AI imaging tools
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