Elucid's FDA-cleared AI estimates whether a clogged heart artery is starving blood flow, and it counts the plaque, not just the narrowing

Elucid, a Boston medical-imaging software company, said on Wednesday, Oct. 21, 2026, that the FDA has cleared FFR-IQ, AI software that estimates fractional flow reserve, a measure of whether a narrowed coronary artery is limiting blood flow, from a coronary CT angiography scan, and that the product is now commercially available.

Heart catheterizations are expensive, invasive, and a lot of them end with the doctor finding that the blockage wasn't limiting flow after all. Software that answers that question from a CT scan the patient already had is a real prize, which is why FFR-CT is already a crowded, reimbursed category. Elucid's angle is that plaque matters, not just how narrow the pipe looks, and its accuracy numbers are strong on paper. But they come from the company's own study, the full data isn't out until TCT on Nov. 1, and "most accurate" across different trials is a comparison doctors will want to check themselves. The clearance also landed on Sept. 29; today's news is that it's for sale.

FFR-IQ is software that estimates fractional flow reserve from a coronary CT angiography scan, using AI-enabled algorithms. Fractional flow reserve, shortened to FFR, is a measure of whether a narrowing in a coronary artery is limiting blood flow to the heart muscle. Doctors have usually measured it with a pressure wire threaded in during a cardiac catheterization, an invasive procedure. Coronary CT angiography, shortened to CCTA, is a CT scan of the heart's arteries. The estimate made from that scan is called FFR-CT. Those lines are Elucid's and the FDA's.

Elucid calls its approach BioIntegrated FFR-CT. It feeds the shape of the arteries and the makeup of the plaque, from its Plaque-IQ software, into the blood-flow estimate. Plaque is the material that builds up inside an artery wall. Other FFR-CT software models the physiology mostly from how the vessel is shaped. Elucid's pitch is that what the plaque is made of changes the answer. Those lines are Elucid's.

The FDA cleared FFR-IQ through 510(k) K262015. A 510(k) is the agency's clearance path for a device it judges similar enough to one already allowed on the market. The decision letter is dated Sept. 29, 2026. The device is Class II, in the category "coronary vascular physiologic simulation software device." It is cleared for clinically stable patients with suspected coronary artery disease. The results are meant to support a qualified clinician, read next to the patient's history, symptoms, and other tests. Elucid announced the clearance, and that hospitals and imaging centers can buy the software now, on Oct. 21. The company has not published a price.

The accuracy numbers come from Elucid's ELUCIDATE FFR-CT study, cited in the 510(k) summary. Sensitivity was 92.2% and specificity was 93.1%. Sensitivity, here, is how often the software caught a narrowing that really was limiting flow, judged against the invasive wire. Specificity is how often it correctly said a narrowing was not limiting flow. Elucid says those are the highest figures reported for any FDA-cleared FFR-CT validation study. The study measured that diagnostic match. It did not measure whether patients had fewer procedures or better outcomes afterward. Elucid says the full results will be presented at the TCT cardiology conference in San Diego on Sunday, Nov. 1, 2026.

Elucid's claim for the product is that estimating FFR without a catheter can help show which patients are likely to benefit from an invasive look and treatment, "potentially helping avoid the majority of unnecessary catheterizations," while also catching flow-limiting disease that the shape of the artery alone may miss. A catheterization, here, is the invasive procedure with the wire. That claim is Elucid's.

Elucid is putting FFR-IQ and Plaque-IQ on one platform, with a new interface and a new reporting workflow, both read from a single CCTA. Plaque-IQ, Elucid says, is the only FDA-cleared CT plaque platform trained and validated on histology. Histology is tissue examined under a microscope, rather than only on a scan. Those lines are Elucid's.

Chief executive Kelly Huang, PhD, said, "Physicians have told us they want a more accurate FFR-CT, and we're thrilled to deliver on that need with the most accurate." Amir Ahmadi, MD, at the Icahn School of Medicine at Mount Sinai and Elucid's lead scientific advisor, said, "Plaque composition, coronary anatomy, and physiology are closely connected." Those quotations are theirs.

In plain terms, Elucid said on Wednesday that the FDA cleared FFR-IQ on Sept. 29 and that hospitals and imaging centers can buy it now. The software reads a coronary CT the patient already had and estimates whether a narrowed artery is starving the heart muscle of blood, counting the plaque as well as the narrowing. Elucid says its own study matched an invasive wire 92.2% of the time when flow was limited and 93.1% of the time when it was not. No price is published. The full study is set for Nov. 1.