FDA Clear Elucid’s Biointegrated FFR-IQ Software for Coronary CTA

October 21, 2026—Elucid, a developer of artificial intelligence (AI)–powered cardiovascular imaging software, announced FDA 510(k) clearance of its FFR-IQ software for noninvasive estimation of fractional flow reserve from coronary CTA (FFR-CT).

According to the company, FFR-IQ features the company’s new biointegrated FFR-CT, which incorporates coronary anatomy and plaque composition into the estimation of coronary physiology to support more accurate individualized assessment and more precise treatment decisions.

The company stated that FDA clearance was supported by the ELUCIDATE FFR-CT study, which validated the diagnostic performance of its biointegrated FFR-CR product with an overall sensitivity of 92.2% and specificity of 93.1%.

Results of the ELUCIDATE FFR-CT study will be presented on November 1 at the TCT 2026 in San Diego, California, noted Elucid.

Elucid further stated it is bringing FFR-IQ together with its FDA-cleared Plaque-IQ plaque platform in a comprehensive clinical platform that integrates coronary anatomy, physiology, and plaque biology from a single coronary CTA, supported by a new interface and reporting workflow.

Amir Ahmadi, MD, Clinical Associate Professor of Medicine (Cardiology) at the Icahn School of Medicine at Mount Sinai in New York, New York, serves as Elucid’s lead scientific advisor.

“Plaque composition, coronary anatomy, and physiology are closely connected,” commented Dr. Ahmadi in the Elucid press release. “Biointegrated FFR-CT incorporates anatomy and plaque characteristics into the physiological estimate itself. Together with plaque assessment, this approach can help physicians evaluate the significance of an individual lesion while also addressing the patient’s broader atherosclerotic disease and need for preventive treatment.”