Elucid wins FDA 510(k) clearance for FFR-IQ, an AI FFR-CT tool with 92.2% sensitivity

What Elucid announced

Elucid, a Boston company that builds AI software for cardiovascular imaging, announced on 21 October 2026 that the US Food and Drug Administration had granted 510(k) clearance to FFR-IQ. The software estimates fractional flow reserve (FFR) from a coronary CT angiography scan, a method usually called FFR-CT. Invasive FFR is measured with a pressure wire during cardiac catheterization and shows whether a narrowing limits blood flow to the heart muscle. Doctors use it to decide whether a patient needs a stent or bypass surgery.

The FDA database lists the device as Elucid FFR-IQ (B.1) under number K262015. The application was received on 15 June 2026 and cleared on 29 September 2026 as a Traditional 510(k), in the class II category for coronary vascular physiologic simulation software. Elucid says the product is now commercially available. It gives no price.

What is different about FFR-IQ

Elucid calls its method BioIntegrated FFR-CT. Most FFR-CT tools model blood flow from the shape of the artery. Elucid says FFR-IQ also feeds plaque composition into the physiology estimate, using measurements from Plaque-IQ, its existing FDA-cleared plaque analysis software. Plaque-IQ measures stenosis, plaque burden and plaque type, including lipid-rich necrotic core. Elucid says it is the only CT plaque platform trained and validated on histology. The company argues that two lesions with similar narrowing can affect blood flow differently depending on the plaque inside them.

The clearance rests on the ELUCIDATE FFR-CT study. Elucid reports an overall sensitivity of 92.2% and specificity of 93.1% against invasive FFR, and calls this the highest of any FFR-CT validation study. The press release does not give the number of patients or vessels. Full results are due at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego on 1 November 2026. Chief executive Kelly Huang says physicians asked for a more accurate FFR-CT.

Why it matters for cardiology teams

Elucid argues that a better noninvasive estimate could help avoid most unnecessary catheterizations while still finding flow-limiting disease that anatomy alone misses. That is a vendor claim until independent sites publish their own numbers. The practical change is that a hospital can get anatomy, plaque and physiology from one CT scan in one product, instead of combining a plaque tool with a separate FFR-CT service.

The clearance also fits a pattern in cardiac AI. In September 2026 the FDA granted a De Novo authorization to Powerful Medical's Queen of Hearts for AI reading of ECGs. More approvals and hospital deployments are tracked under AI in Industry.

What to watch next

The TCT presentation on 1 November should show the study size and how results vary by lesion type. Buyers will also look for reimbursement details and for head-to-head data against established FFR-CT products, which the announcement does not include.

Questions people ask

What is FFR-CT?

It is a noninvasive estimate of fractional flow reserve calculated from a coronary CT angiography scan, used to judge whether a narrowed artery limits blood flow without inserting a pressure wire.

How accurate is Elucid FFR-IQ?

Elucid reports 92.2% sensitivity and 93.1% specificity in its ELUCIDATE FFR-CT study, measured against invasive FFR. The study size is not stated in the announcement.

When did the FDA clear FFR-IQ?

The FDA decision under 510(k) number K262015 is dated 29 September 2026. Elucid announced it on 21 October 2026.

Sources

1. Elucid Announces FDA Clearance of FFR-IQ and Commercial Availability of the Most Accurate FFR-CT Software (Elucid, 21 Oct 2026)
2. 510(k) record K262015: Elucid FFR-IQ (B.1) (U.S. Food and Drug Administration (openFDA), 29 Sep 2026)