TL;DR: Elucid received FDA 510(k) clearance for FFR-IQ, its AI-enabled FFR-CT software, and announced commercial availability on Oct. 21, 2026.

Clearance announced and now commercially available

Elucid, described as an innovator of AI-powered cardiovascular imaging software, announced U.S. Food and Drug Administration 510(k) clearance of FFR-IQ and its commercial availability on Oct. 21, 2026, according to the Business Wire announcement titled Elucid Announces FDA Clearance of FFR-IQ and Commercial Availability of the Most Accurate FFR-CT Software.

The announcement identifies FFR-IQ as software for noninvasive estimation of fractional flow reserve from coronary CT angiography, known as FFR-CT. The company presents FFR-IQ as introducing BioIntegrated FFR-CT, which incorporates coronary anatomy and plaque composition into estimation of coronary physiology to support individualized assessment and treatment decisions, according to that Business Wire announcement.

A separate Associated Press relay of the Business Wire release carries the same announcement date and description. The AP relay similarly describes Elucid as an innovator of AI-powered cardiovascular imaging software and FFR-IQ as software for noninvasive estimation of fractional flow reserve from coronary CT angiography.

Elucid calls FFR-IQ the most accurate FFR-CT software, with a superscript reference mark in the headline. That comparative accuracy language is the company's characterization in its announcement, not language used in the FDA clearance letter itself.

FDA decision details for K262015

The clearance is documented as 510(k) number K262015 for Elucid FFR-IQ (B.1), according to the Innolitics summary of FDA 510(k) data and the FDA clearance letter.

The FDA letter is dated Sept. 29, 2026, and addressed to Windi Hary, Chief Quality and Regulatory Officer of Elucid Bioimaging Inc. at 399 Boylston St., Suite 400, Boston, Massachusetts 02116. It identifies the regulation number as 21 CFR 870.1415, the regulation name as Coronary Vascular Physiologic Simulation Software Device, the regulatory class as Class II, and the product code as PJA.

The letter states that the submission was dated Aug. 28, 2026, and received Aug. 31, 2026. It states that FDA reviewed the premarket notification and determined the device is substantially equivalent for the indications for use stated in the enclosure to legally marketed predicate devices, and that Elucid may therefore market the device subject to general controls provisions of the Federal Food, Drug, and Cosmetic Act.

The letter also notes requirements including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. It states that device labeling must be truthful and not misleading, and that additional controls may apply for Class II devices.

What the software is indicated to do

According to the Innolitics summary of FDA 510(k) data, Elucid FFR-IQ is a coronary physiological simulation software for clinical quantitative and qualitative analysis of previously acquired computed tomography DICOM data for clinically stable patients with known or suspected coronary artery disease.

The summary states that it provides FFR-CT values estimated from coronary CTA images using AI-enabled algorithms. It states that FFR-IQ is intended to support functional evaluation of coronary artery disease, with results provided to support qualified clinicians in evaluation and assessment of coronary arteries.

The indicated use calls for qualified clinicians to use FFR-IQ results in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment, according to that Innolitics summary. The summary further describes the indicated population as clinically stable adult patients age 22 years and older with known or suspected coronary artery disease requiring functional evaluation through analysis of previously acquired coronary CTA images.

How BioIntegrated FFR-CT differs by design

Traditional computational approaches to CT-derived FFR model physiology primarily from anatomical geometry, while Elucid's BioIntegrated approach treats coronary arteries as living vessels rather than rigid pipes, according to Elucid's healthcare-professionals information.

That company information states that FFR-IQ goes beyond physical properties of the vessel and lesion to include biological and morphological properties. It states that vessel performance during maximum hyperemia depends on plaque composition, making highly accurate plaque analysis and FFR-CT both necessary for treatment decisions.

The Innolitics summary states that FFR-IQ is delivered as Software-as-a-Service that takes previously acquired coronary CTA DICOM images as input. It states that the device uses deep learning neural networks to integrate coronary anatomy and biology, including plaque composition and amount, to estimate FFR-CT values along the coronary tree.

The same summary states that the software utilizes 3D segmentation results from the Plaque-IQ algorithm. Elucid's professional information states that concordance between plaque data and FFR-CT data is possible when both outputs originate from the same source data, and describes its FFR-CT data as plaque-derived.

ELUCIDATE validation study design

Clinical validation was performed through the ELUCIDATE study, identified as NCT06018194, a retrospective multicenter study comparing FFR-IQ values against invasive FFR measurements, according to the Innolitics summary.

The summary states that the study included 491 vessels across 347 patients at 11 sites, including nine in the United States and two outside the United States. It states that invasive FFR was performed within 60 days of coronary CTA, and that data were collected from 2012 onward, reflecting retrospective clinical records of paired CTA and invasive FFR under real-world conditions.

The ClinicalTrials.gov listing for The ELUCIDATE FFRct Study identifies the sponsor as Elucid Bioimaging Inc., the study type as observational cohort, and the status as completed. It lists a start date of Sept. 1, 2023, and completion on July 28, 2025, with actual enrollment of 439 participants.

That ClinicalTrials.gov listing states the goal is to evaluate diagnostic accuracy of plaque-based coronary CTA fractional flow reserve software for estimation of invasive FFR. Inclusion criteria listed include adults older than 18 years with CTA performed with more than 64-detector-row scanners within 60 days of undergoing invasive FFR.

The listing defines study arms by invasive FFR of 0.80 or less versus greater than 0.80, and lists primary outcomes as per-vessel sensitivity and specificity of FFR-CT versus invasive FFR for detecting invasive FFR of 0.80 or less. Secondary outcomes listed include per-patient sensitivity, specificity, area under the receiver-operating characteristic curve, accuracy, negative predictive value, and positive predictive value.

Reported accuracy results

The Innolitics summary reports overall sensitivity of 92.2% with a confidence interval of 87.5 to 96.5, and overall specificity of 93.1% with a confidence interval of 90.2 to 95.6. It reports positive predictive value of 84.4% and negative predictive value of 96.7%.

The acceptance criteria described in that summary were sensitivity greater than 75% and specificity greater than 75%. The observed point estimates exceeded those thresholds in the reported analysis.

For the U.S. cohort of 257 patients, the summary reports sensitivity of 90.9% and specificity of 89.2%. It states that the study population was enriched for borderline disease with FFR values from 0.75 to 0.85, and states that no adverse events were observed because of the retrospective study design.

Elucid's professional information cites research publications and notes that one cited analysis was based on a research version of FFR-CT, not the commercially available version. The company also publishes histology-validation correlations for its Plaque-IQ algorithms, but those correlations describe plaque software validation rather than FFR-IQ clearance.

How clinicians receive and use results

The Innolitics summary states that FFR-IQ is used in healthcare facilities, hospitals, or physician offices, with qualified clinicians accessing graphics and text results through an internet-connected device. It describes connectivity as internet-based access for end users.

Elucid's professional information states that Plaque-IQ delivers plaque quantification, luminal stenosis, and stenosis evaluation with a lesion-level view, including a clinical dashboard and physician-validated PDF report. It describes straightened multi-planar reconstruction for review of plaque distribution and stenosis severity, transparent segmentation with color-coded plaque morphology mapping, and summary cards for plaque burden, highest stenosis, and standardized scoring.

The same company information lists CPT 75574 for coronary CTA, CPT 0623T through 0626T and related coding for Plaque-IQ, and CPT 75580 for FFR-IQ. It states that FFR-IQ is covered by all major insurance providers, in the context of resources intended to help providers navigate billing and reimbursement.

The FDA clearance letter for K262015 does not establish reimbursement or coverage. Coverage information comes from Elucid's professional site, while the authorization to market comes from FDA.

Company and commercial context

On Sept. 2, 2026, Elucid announced a $55 million oversubscribed Series D financing, bringing total funding raised to approximately $185 million, according to Elucid's financing announcement. That announcement lists participation from new and existing investors including IAG Capital Partners and Elevage Medical Technologies, plus new participation from a large medtech company described as Elucid's fourth publicly traded strategic investor.

That Sept. 2 announcement states that proceeds would be used to accelerate commercial expansion of Elucid's platform, including FFR-CT while its 510(k) submission was under FDA review and Plaque-IQ, as well as AI research and clinical studies. At that time, Elucid said it was preparing for full commercial launch with FDA clearance of its BioIntegrated FFR-CT product designed to offer high accuracy and reproducibility compared with invasive FFR.

The same announcement describes Plaque-IQ as the only FDA-cleared, non-invasive method capable of quantifying the highest-risk plaque type and plaque composition in coronary and carotid arteries with accuracy validated against histopathology. It also states that Elucid converts routine CT angiography into quantitative insights based on plaque biology, vessel anatomy, and FFR physiology to help stratify at-risk patients and personalize treatment for atherosclerotic cardiovascular disease.

With the Oct. 21 announcement, that previously pending FFR-CT submission has now resulted in clearance and commercial availability. The Oct. 21 Business Wire announcement is therefore the completed regulatory and commercial event, while the Sept. 2 financing announcement provides context on funding and launch preparation before clearance.

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