The complaint

The case is Heartflow, Inc. v. Elucid Bioimaging Inc., No. 1:26-cv-14793 (D. Mass.), filed October 22, 2026 and assigned to Judge Allison D. Burroughs. The 179 page complaint pleads infringement of four patents (Counts I to IV), misappropriation under the Defend Trade Secrets Act, 18 U.S.C. 1836 (Count V), and misappropriation under the Massachusetts Uniform Trade Secrets Act, M.G.L. c. 93, sections 42 to 42G (Count VI). It says Heartflow is a Delaware corporation based in San Francisco and alleges, on information and belief, that Elucid is a Delaware corporation based in Boston, founded in 2013, that develops AI-powered cardiovascular imaging software. Venue on the patent counts is pleaded under 28 U.S.C. 1400(b), on the allegation that Elucid has committed acts of infringement and has a regular and established place of business in the district. The complaint is signed by Aaron S. Jacobs of Prince Lobel Tye LLP and also lists attorneys of Mayer Brown LLP.

The FDA clearance at the center of the case

The complaint alleges that the FDA cleared Elucid FFR-IQ on September 29, 2026 under 510(k) number K262015, and that Elucid's submission identified one predicate device, Heartflow's FFRCT product (DEN130045), which the complaint says received de novo clearance on November 26, 2014. It alleges that Elucid's comparison table described its device as the "[s]ame as predicate" in product code, regulation, and classification.

The four patents

U.S. Patent 9,754,082, "Systems and methods for reporting blood flow characteristics," issued September 5, 2017. Claim 1 covers a system with at least one computer that receives patient-specific image data of the geometry of the patient's heart, creates a model of blood flow through at least part of an artery of the heart, determines a value of a blood flow characteristic non-invasively from that model, and generates a display with at least three parallel, coextensive representations of the artery segment: a line plot of the value from the proximal end to the distal end, an image of the anatomy aligned with that axis, and a model of the artery with an indicator of the value. The complaint asserts at least claims 1 to 18.

U.S. Patent 10,010,255, "Systems and methods for estimating ischemia and blood flow characteristics from vessel geometry and physiology," issued July 3, 2018. Claim 1 covers a method of determining fractional flow reserve (FFR) for a stenosis by extracting anatomical or geometric features of the stenosis from the patient's medical image data, training a machine learning algorithm on measured FFR values and features from a plurality of individuals, using the trained algorithm to determine an FFR value for the patient, and generating and displaying a geometric model of the stenosis that indicates the value. The complaint asserts at least claims 1 to 4.

U.S. Patent 9,770,303, "Systems and methods for predicting coronary plaque vulnerability from patient-specific anatomic image data," issued September 26, 2017. Claim 1 covers a computer-implemented method of predicting a patient's cardiac risk by analyzing the patient's anatomical image data, determining coronary plaque vulnerability at a selected location, building vascular geometry models and numerical descriptions of risk factors for a plurality of other individuals, generating a patient-specific numerical description from them, and predicting cardiac risk from the plaque vulnerability and that description. The complaint asserts at least claims 1 to 20.

U.S. Patent 9,070,214, "Systems and methods for data and model-driven image reconstruction and enhancement," issued June 30, 2015. Claim 1 covers a method that acquires image information for a target anatomy, determines subdivisions of localized anatomy within a collection of images, determines associations between image regions and those subdivisions, and generates an image reconstruction or enhancement based on the image information and the associations. Claim 2 adds determining image priors from the associations and basing the reconstruction or enhancement on them. The complaint alleges direct infringement of at least claims 2, 4, 5, 7, and 8 and indirect infringement of at least claims 1 and 2.

The accused products

For the '082 and '255 patents, the complaint accuses Elucid FFR-IQ, which it says is also referred to as BioIntegrated FFR-CT or plaque-based FFRCT, alone or with Elucid's Plaque-IQ software. For the '303 patent it accuses Plaque-IQ, including its Lesion Inspection Tool, and for the '214 patent it accuses Plaque-IQ's image-restoration algorithms, CT Virtual Histology processing, and viewer. Each patent count also alleges induced and contributory infringement and willful infringement. For willfulness, the complaint points to Elucid's hiring of eleven former Heartflow employees, including Heartflow's former Chief Regulatory and Quality Officer, whom it identifies as the primary correspondent on the FFR-IQ 510(k) submission.

The trade secret claims

The complaint alleges that several former Heartflow employees who joined Elucid, including senior leaders of Elucid's commercial organization, forwarded Heartflow's hospital account lists and contract terms, physician lists, commercialization and reimbursement know-how, market models, revenue forecasts, business plans, and sales performance data to personal email accounts shortly before leaving Heartflow. It alleges that Heartflow raised concerns in writing when Elucid hired its former regulatory chief in September 2023, and that Elucid replied in a September 21, 2023 letter that it "respects the confidentiality and intellectual property of other companies, including Heartflow."

The relief sought

Heartflow asks for a judgment of infringement, damages including lost profits and no less than a reasonable royalty, enhanced damages for willful infringement, attorneys' fees under 35 U.S.C. 285, and a permanent injunction. On the trade secret counts it asks for an injunction against use or disclosure, return of the information, an order barring Elucid from making, selling, or seeking further regulatory clearance for any product, including FFR-IQ, developed or cleared using the trade secrets, an accounting and constructive trust, damages, exemplary damages of up to two times, and fees. Heartflow demands a jury trial.

What to watch next

Watch for service and Elucid's answer or Rule 12 motion, any motion for a preliminary injunction on the trade secret counts, and any petitions for inter partes review of the four patents.