Elucid Software Matches Invasive FFR in Study
Elucid's FFR-IQ software showed 92.9% vessel-level accuracy against invasive fractional flow reserve at a TCT 2026 presentation.
Updated on Nov. 3, 2026 in Heart Disease
Elucid presented a study of its FFR-IQ software at the TCT 2026 conference in San Diego, reporting 92.9% vessel-level diagnostic accuracy compared with invasive fractional flow reserve. The results support the software's recent FDA 510(k) clearance.
Why it matters
FFR-IQ estimates FFR values from existing coronary CT angiography scans, which may offer a way to assess coronary blockages without a separate invasive procedure. The study met both of its primary endpoints across 11 U.S. and European institutions.
The Elucidate study compared FFR-IQ with invasive FFR across 491 coronary vessels from 347 patients, yielding 92.9% vessel-level accuracy, 92.2% sensitivity and 93.1% specificity. In the borderline gray zone of invasive FFR values between 0.75 and 0.85, accuracy was 84.1%, and it is not stated whether performance differs in other populations.
The players
Elucid
Elucid is the company that developed the FFR-IQ software and presented its clinical study at TCT 2026.
U.S. Food and Drug Administration
The FDA is the federal agency that reviews and clears medical devices and software for use in the United States, including FFR-IQ through a 510(k) clearance.
The details
Elucid presented the Elucidate study at TCT 2026 in San Diego, conducted at 11 U.S. and European institutions. FFR-IQ applies a deep-learning model that incorporates coronary anatomy and plaque composition to existing coronary CT angiography scans, estimating FFR values along the coronary vessels.
Timeline
- 2026: Elucid presents the Elucidate study at the TCT 2026 conference in San Diego.
- Recent, before the announcement: FFR-IQ receives FDA 510(k) clearance.
Health Landscape
The study positions a CT-derived estimate as a potential alternative to invasive fractional flow reserve, the pressure-wire standard used to assess coronary blockages for years. Its results suggest that imaging-based tools may increasingly be evaluated against that long-established reference measurement.
If validated for routine use, a CT-based FFR estimate could allow some patients with suspected coronary blockages to be assessed without a separate invasive procedure. Patients should discuss with their cardiologist whether any imaging-based test fits their situation.
The takeaway
Imaging-based tools that estimate coronary blockage severity are being tested against the established invasive standard. Readers with heart concerns should continue to rely on their clinicians' guidance on diagnostic options.
Further reading
Explore more on Heart Disease to see how coronary imaging and diagnostics fit into current cardiac care.
Source note: This article includes information reported by AuntMinnie.
