Heartflow Sues Elucid Over FFR-IQ Patents and Trade Secrets After FDA Clearance
Heartflow alleges patent infringement and trade secret misappropriation over Elucid's FFR-IQ, and Elucid says it will defend itself. For CCTA departments, the filing is a legal dispute whose claims remain allegations, not findings.
Significance 3/10: Heartflow is now suing both main AI coronary CT rivals, but the claims remain untested allegations.
Coverage we found: 4 trade outlets, no mainstream news Since the complaint was filed on October 22, 2026, through October 27, 2026. (searched October 27, 2026).
How we scored this
- Strength of evidenceThe article reports allegations in a complaint through secondary trade reports and a defendant's statement, and no court has ruled on them.
- Effect on practice or understandingNothing in the article changes imaging practice, guidelines or an accepted account, and the article says the FDA clearance does not resolve the patent allegations.
- ReachThe dispute concerns software for coronary CT angiography, so it touches one specialty (cardiac imaging departments and vendors).
- StakesThe article describes possible damages and a jury trial, but it reports no safety, dose or pricing consequences.
- SurpriseIt follows Heartflow's April 2026 suit against Cleerly, so a second suit is expected, though the 11-employee hiring allegation adds specifics.
Coverage found
- AuntMinnie trade press, 2026-10-26
- Cardiovascular Business trade press, 2026-10-26
- Law360 trade press
- Bloomberg Law trade press
- BioPharmaWatch (repost of Elucid's Business Wire statement; also Yahoo Finance and Rallies.ai) other, 2026-10-23
Only news, trade and journal coverage is counted. Press releases and other sources, such as reference sites, blogs, social posts and stock-news reprints, are listed but not counted. Searches miss things: tell us about coverage we missed. How the Unread Index works.
Heartflow, which sells FFRct Analysis software for CT-derived fractional flow reserve (FFR-CT), sued Elucid on October 22, 2026, in the U.S. District Court for the District of Massachusetts. The complaint accuses Elucid of infringing four Heartflow patents and misappropriating trade secrets to build FFR-IQ, a competing product that estimates coronary physiology from coronary CT angiography (CCTA), AuntMinnie reported. The suit was filed about three weeks after the FDA cleared FFR-IQ.
It’s Heartflow’s second patent case this year against an AI-CCTA rival. In April 2026, Heartflow sued Cleerly in the U.S. District Court for the Eastern District of Texas. Cardiovascular Business calls Elucid one of Heartflow’s primary competitors and Cleerly one of its biggest rivals. For departments that run CCTA and buy physiology or plaque analysis software, Heartflow is now in federal court against both of the companies the trade press treats as its main challengers.
The most specific allegation is about people, not code. Heartflow alleges that Elucid hired 11 of its employees who had knowledge of Heartflow’s product design, patents, regulatory submissions, commercialization plans and customer lists, Law360 reported. The complaint also alleges that other senior staff who left for Elucid took information such as physician and hospital account lists.
What Heartflow alleges about FFR-IQ
The asserted patents are U.S. Patent Nos. 9,754,082; 10,010,255; 9,770,303; and 9,070,214, according to Bloomberg Law.
The complaint also puts images of FFR-IQ beside images of FFRct Analysis and highlights how similar they look, Cardiovascular Business reported. It describes the case as “egregious violations of Heartflow’s intellectual property rights by Elucid.” Heartflow wants a jury trial and damages, and among the harms it lists is an alleged “unearned head start.” Heartflow said it isn’t commenting beyond what’s in the complaint.
The FDA’s 510(k) database lists K262015, “Elucid FFR-IQ (B.1),” as substantially equivalent, with a decision date of September 29, 2026, under product code PJA. That is a 510(k) clearance, and it does not resolve Heartflow’s patent allegations.
Elucid’s response and the Cleerly case
Elucid said in a statement released October 23 that it will respond to and defend against the claims through the appropriate legal channels. CEO Kelly Huang said the company is confident in its independent development. Elucid describes FFR-IQ as providing noninvasive assessment of coronary physiology derived from its plaque analysis. Elucid’s Plaque-IQ is FDA-cleared software that the company says quantifies and characterizes atherosclerotic plaque in coronary and carotid arteries.
The Cleerly suit, described in Cardiovascular Business’s coverage, follows a similar pattern. It alleges that Cleerly’s AI-powered CCTA software infringes six Heartflow patents, and it highlights the time Dr. James K. Min, Cleerly’s founder and CEO, spent as a Heartflow consultant. Cardiovascular Business also reported that Cleerly brought in Brent Ness, a Heartflow executive from 2014 to 2015, as president and chief commercial officer from 2019 to 2021. Heartflow is seeking damages, including years of lost profits, and a jury trial.
Min said, “We are confident in our extensive and well-established intellectual property portfolio and the originality of our technology.”
Screenshots and an open question
The screenshots deserve caution. Two programs that display the same kind of physiological estimate on the same kind of coronary anatomy may look alike. A resemblance in output images doesn’t by itself establish infringement or misappropriation.
One question remains open: whether Heartflow will seek a preliminary injunction against FFR-IQ. None of the checked sources reports such a request.
About the sources: The complaints and the Law360 and Bloomberg Law articles were not reviewed directly. The hiring allegation, attributed to Law360, and the patent numbers, attributed to Bloomberg Law, come through AuntMinnie’s reporting. Cardiovascular Business quoted the complaint. These outlets describe the same filing. Elucid’s statement confirms that the suit exists and when it was filed. The Cleerly details come from Cardiovascular Business’s coverage of that separate case, and the clearance details come from the FDA 510(k) record.
Edited by a healthcare imaging professional with more than 25 years of experience in the field. How we report and edit.
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