THE ARISING · Longevity & Healthspan
FDA Clears AI Software Gauging Heart Artery Blockages From CT Scans
The US Food and Drug Administration has cleared software that uses artificial intelligence to estimate whether a narrowed heart artery is actually limiting blood flow, working from a standard CT scan rather than a wire placed inside the heart.
According to AuntMinnie, which reported the news on October 21, 2026, Boston-based Elucid received FDA 510(k) clearance for FFR-IQ. The measure it estimates is called fractional flow reserve. It shows whether a narrowing in a coronary artery truly restricts blood flow. Until now, the direct way to measure it has been an invasive pressure wire.
FFR-IQ works from coronary CT angiography, a scan of the heart's arteries. According to the report, it also factors in plaque composition, including the lipidrich necrotic core, a fatty part of plaque linked to heart attacks. That plaque information comes from Elucid's Plaque-IQ software.
The company reports that in its ELUCIDATE FFR-CT validation study, FFR-IQ had 92.2% sensitivity and 93.1% specificity compared with invasive wire-based measurement. In plain terms, sensitivity is how often the software flagged narrowings that the wire test found were limiting flow. Specificity is how often it correctly cleared those that were not. These figures come from the company. The report gives no study size, no independent review, no pricing and no guideline status.
Elucid is combining FFR-IQ and Plaque-IQ into one platform that assesses anatomy, physiology and plaque from a single scan.
What to watch next
Independent studies confirming the accuracy figures, and whether medical guidelines and insurers adopt the tool.