Elucid Bioimaging has won FDA 510(k) clearance for FFR-IQ, software that estimates coronary blood flow from a CT scan while also reading plaque composition in the same image — the third such FFR-CT product FDA has cleared in the US, and one that drew a patent and trade-secret lawsuit from the company whose product it was cleared against, filed one day after the news became public.
FFR-IQ's clearance in four figures
Figures from Elucid's 21 October 2026 clearance announcement; the ELUCIDATE trial has not yet been independently published or presented (full results are scheduled for TCT 2026, 1 November).
Third into a category HeartFlow built
Elucid Bioimaging has won FDA clearance for FFR-IQ, software that estimates fractional flow reserve — a measure of how much a coronary-artery narrowing actually restricts blood flow — directly from a standard coronary CT angiogram, without the invasive wire-based procedure FFR traditionally requires. FDA's decision, dated 29 September 2026 and announced publicly on 21 October, makes FFR-IQ the third such product cleared in the US. The clearance record says as much: FDA found FFR-IQ substantially equivalent to FFRct, the FFR-CT software HeartFlow brought to market more than a decade earlier.
“Physicians have told us they want a more accurate FFR-CT, and we’re thrilled to deliver on that need with the most accurate.” Kelly Huang, PhD, President and Chief Executive Officer, Elucid Bioimaging — 21 October 2026 announcement
What plaque data adds to a flow score
Where HeartFlow's and Keya Medical's cleared products estimate flow from coronary anatomy alone, FFR-IQ layers in plaque-composition data drawn from Elucid's own Plaque-IQ software, cleared in 2024. The company brands the combination “BioIntegrated FFR-CT” and says it is now combining FFR-IQ and Plaque-IQ into one reporting workflow from a single scan. Whether that combination changes clinical decisions more often than a flow-only read is the open question the ELUCIDATE trial was built to answer — and a question outside reviewers have not yet had the chance to examine.
Three things that separate FFR-IQ from the first two FFR-CT tools
One scan, two readings
FFR-IQ pairs Elucid's existing plaque-composition analysis with a flow estimate from the same coronary CT scan, instead of reporting flow alone the way the category's first two cleared products originally did.
A later, not a first, entrant
FFR-IQ was cleared as substantially equivalent to HeartFlow's FFRct, the product FDA names as its predicate — the third FDA-cleared FFR-CT tool in the US, after HeartFlow's original 2014 clearance and Keya Medical's DeepVessel FFR in 2022.
Accuracy not yet published
Elucid's 92.2% sensitivity and 93.1% specificity figures come from its own ELUCIDATE study announcement; the trial's full results have not yet been peer-reviewed or presented, with that presentation scheduled for TCT 2026 on 1 November.
A lawsuit filed the day after clearance
The clearance did not stay uncontested for long. On 22 October 2026, HeartFlow sued Elucid in federal court in Massachusetts, alleging patent infringement and trade-secret misappropriation tied directly to FFR-IQ. HeartFlow's complaint says Elucid hired 11 of its former employees who knew its product design, regulatory submissions and customer lists, and it points to visual similarities between FFR-IQ's interface and its own FFR_CT Analysis software. Elucid has said it is reviewing the allegations and will defend itself through the appropriate legal channels; no court has ruled on the claims, and the dispute has no bearing on FFR-IQ's underlying FDA clearance.
The spread between three market forecasts
Market researchers do not agree closely on how big the FFR-CT opportunity is. Estimates for the global FFR-CT software market range from roughly $390 million to $725 million for 2025 alone, depending on which firm's methodology is used, with later-decade forecasts spreading further still. Regulatory News uses Emergen Research's published figures below as one consistent, citable baseline — not as a consensus the market research itself lacks.
What a crowded FFR-CT field is worth
$0.45B → $1.2B
Global FFR-CT (fractional flow reserve CT) software market, 2024 to 2034, as forecast by Emergen Research.
Sources: Emergen Research, Fractional Flow Reserve Computed Tomography (FFR-CT) Market report
Regulatory News outlook
We expect FFR-IQ to compete for share of an FFR-CT market that already has two FDA-cleared rivals, rather than create a new category outright; its plaque-integrated design is a genuine product difference, not by itself evidence of faster adoption.
How we got here: Emergen Research's published 10.0% compound annual growth rate on its $0.45 billion 2024 estimate reaches roughly $1.2 billion by 2034; we treat Elucid's share of that growth as split three ways with HeartFlow and Keya Medical rather than additive, since all three now compete for the same referring cardiologists.
FFR-IQ against the two FDA-cleared rivals it now competes with
| Product | What it adds to flow | US status | Maker |
|---|---|---|---|
| FFR-IQ (Elucid Bioimaging) | Plaque-composition data layered on the flow estimate | FDA 510(k) cleared, Sep 2026 (K262015) | Private |
| FFRct (HeartFlow) | Coronary anatomy and flow; plaque sold as a separate add-on product | FDA cleared, first version 2014, updated since | Private |
| DeepVessel FFR (Keya Medical) | Coronary anatomy and flow | FDA 510(k) cleared, Apr 2022 (K213657) | Private |
From each company's own FDA clearance records and public filings; not a clinical comparison.
Thirteen years from a histology-validated plaque tool to FFR-IQ
FFR-IQ is Elucid's fourth FDA clearance in nine years, not its first attempt at proving CT-based plaque and flow analysis can stand in for more invasive testing.
Elucid's road from vascuCAP to FFR-IQ
- 2013
Elucid Bioimaging founded
Founded in Boston, Massachusetts.
- 24 May 2017
vascuCAP cleared
FDA clears vascuCAP, Elucid's first CT plaque-analysis software and, the company says, the first FDA-cleared, CE-marked, histology-validated tool of its kind (510(k) K163071).
- 12 September 2024
Plaque-IQ cleared
FDA clears Plaque-IQ, Elucid's coronary plaque-quantification software (510(k) K241524), weeks before Kelly Huang, PhD becomes President and CEO.
- 2 September 2026
$55 million Series D
Elucid closes an oversubscribed Series D financing, with participants including IAG Capital Partners and Elevage Medical Technologies, taking total funding to roughly $185 million.
- 29 September 2026
FDA clears FFR-IQ
FDA clears FFR-IQ (510(k) K262015) as substantially equivalent to HeartFlow's FFRct.
- 22 October 2026
HeartFlow sues Elucid
HeartFlow files suit in federal court in Massachusetts, alleging Elucid built FFR-IQ using patents and trade secrets carried over by former HeartFlow employees it hired; Elucid says it will defend itself.
- 1 November 2026
ELUCIDATE results due at TCT
Elucid's full ELUCIDATE FFR-CT validation results are scheduled for presentation at the Transcatheter Cardiovascular Therapeutics conference in San Diego.
What the clearance does not yet show: whether FFR-IQ changes a cardiologist's treatment decision more often than a flow-only read, whether its company-reported accuracy numbers hold up once ELUCIDATE's full results reach independent review, and how the HeartFlow lawsuit — filed one day after the product reached the market — resolves.
- Clearance: FDA 510(k) K262015, decision dated 29 September 2026, publicly announced 21 October 2026, as substantially equivalent to HeartFlow's FFRct.
- Evidence: 92.2% sensitivity and 93.1% specificity against invasive FFR, across 491 vessels in 347 patients — company-reported; full results are not yet peer-reviewed or presented.
- Litigation: HeartFlow sued Elucid on 22 October 2026 over patents and trade secrets it says follow 11 former HeartFlow employees Elucid hired; no court ruling has been reported.
- Not yet public: a dedicated FFR-IQ product page confirming current indications and limitations, and how Elucid's FDA submission data compares with the validation numbers now scheduled for TCT 2026.
Sources & further reading
- Elucid Bioimaging, FDA clearance announcement for FFR-IQ (via BusinessWire), 21 October 2026. financialcontent.com
- AuntMinnie, "Elucid gets FDA clearance for plaque-informed FFR-CT software," 21 October 2026. auntminnie.com
- HIT Consultant, "Elucid Scores FDA Clearance for FFR-IQ to Unify Plaque Biology and Hemodynamics," 21 October 2026. hitconsultant.net
- Cardiovascular Business, "FDA clears Elucid's new AI-enabled FFR-CT software." cardiovascularbusiness.com
- Cardiovascular Business, "Heartflow sues AI rival Elucid over alleged IP violations." cardiovascularbusiness.com
- Bloomberg Law, "Heartflow Says Elucid Stole Trade Secrets, Infringed Patents." news.bloomberglaw.com
- ClinicalTrials.gov, ELUCIDATE FFR-CT Study, NCT06018194. clinicaltrials.gov
- Emergen Research, Fractional Flow Reserve Computed Tomography (FFR-CT) Market report. emergenresearch.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What did FDA actually clear for Elucid?
FFR-IQ, software that estimates fractional flow reserve from a standard coronary CT angiogram while also factoring in plaque-composition data from Elucid's Plaque-IQ software. FDA's clearance decision (510(k) K262015) is dated 29 September 2026; Elucid announced it and made FFR-IQ commercially available on 21 October 2026.
Is FFR-IQ the first product of its kind?
No. FDA cleared FFR-IQ as substantially equivalent to HeartFlow's FFRct, which HeartFlow brought to market beginning in 2014, and Keya Medical's DeepVessel FFR has held its own FDA clearance since April 2022. FFR-IQ is the third FDA-cleared FFR-CT product in the US; its distinguishing feature is folding in plaque-composition data, not being first to market.
What is the HeartFlow lawsuit about?
On 22 October 2026 — one day after Elucid announced FFR-IQ's clearance — HeartFlow sued Elucid in the US District Court for the District of Massachusetts, alleging patent infringement and trade-secret misappropriation. HeartFlow's complaint says Elucid hired 11 of its former employees who had knowledge of its product design and confidential business information. Elucid has said it will defend itself through the appropriate legal channels; no court has ruled on the claims.
Is Elucid Bioimaging a public company?
No. Elucid is privately held, founded in 2013 and based in Boston, Massachusetts. It has raised roughly $185 million across multiple funding rounds, most recently an oversubscribed $55 million Series D in September 2026.
