HeartFlow provides a non-invasive cardiac test that helps doctors visualize a patient’s coronary arteries to diagnose and plan treatment for heart disease. It uses a proprietary set of analyses—FFRCT Analysis, RoadMap Analysis, Plaque Analysis, and HeartFlow Planner—to create a detailed, patient-specific visualization from imaging data, enabling clinicians to assess blood flow and plaque without surgery. This approach reduces the need for invasive procedures, lowers risk for patients, and can cut costs for healthcare providers. Compared with traditional methods, HeartFlow offers validated, FDA-cleared tools that integrate multiple analyses into one platform, giving physicians a clearer, data-driven basis for diagnosis and treatment decisions. The company’s goal is to improve cardiovascular care by making safer, more efficient diagnosis and treatment planning widely available in hospitals and clinics around the world.
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Company Size
501-1,000
Company Stage
IPO
Headquarters
San Francisco, CA
Founded
2010
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Heartflow (Nasdaq: HTFL) said a 1,105-patient randomised trial found that CT-guided heart stent planning matched intravascular ultrasound (IVUS) on one-year outcomes. The P4 results were presented at the TCT symposium on November 1, 2026, and published in the New England Journal of Medicine. Target-vessel failure at 12 months was 4.1% with CT guidance versus 4.6% with IVUS. Median procedure time fell from 63 to 46 minutes, and contrast volume dropped about 12%. A separate 203-patient registry, NAVIGATE-PCI, found doctors changed treatment plans in about 70% of cases after using Heartflow's PCI Navigator tool. Stent length was the most common change, at 41%.
Boston Scientific lowers 2026 outlook, partners with Heartflow on PCI. The medtech firm revises its annual guidance amid ongoing recovery from a cyber incident and announces a collaboration to support CT-guided PCI. October 28, 2026 Associate Editor Boston Scientific and Heartflow have announced a strategic collaboration to advance CT-guided planning for percutaneous coronary intervention (PCI) in patients with coronary artery disease. The companies will evaluate compatibility between Heartflow's AI-powered PCI Navigator platform, which creates patient-specific 3D coronary models for preprocedural planning, and Boston Scientific's AVVIGO+ multi-modality guidance system, which supports intravascular imaging and physiology assessment during procedures. They'll also explore ways to integrate the technologies to help physicians plan and perform PCI with greater precision and efficiency. "Through this collaboration, we aim to support more informed clinical decision-making and advance a more personalized approach to care for patients with coronary artery disease, from diagnosis through treatment," Heartflow said in an X post announcing the partnership. The collaboration was also revealed in Boston Scientific's Q3 earnings release. Q3 results and 2026 outlook. Boston Scientific reported $5.14 billion in third-quarter 2026 sales, up 1.5% from the same period last year, as a cybersecurity incident disrupted operations and weighed on results. The company lowered its full-year 2026 sales growth outlook to about 4.25% on a reported basis and 3.75% organically. It expects fourth-quarter sales to decline 1% to 3% year over year, and forecasts adjusted earnings of $0.77 to $0.79 per share. The company posted adjusted earnings of $0.73 per share, down from $0.75 a year earlier. The company estimated the cyber incident stifled organic sales growth by approximately 300 basis points, following an eight-business-day disruption that halted manufacturing and shipments across its global network. Cardiovascular sales grew 1.9% to $3.41 billion, while MedSurg sales increased 0.6% to $1.73 billion. Neuromodulation led growth within MedSurg, with sales rising 13% to $331 million. Endoscopy sales declined 0.6% to $741 million, and Urology sales fell 3.1% to $661 million. During the quarter, Boston Scientific received FDA 510(k) clearance for two technologies in its StoneSmart kidney stone treatment portfolio: the Navigator Flex ureteral access sheath set, which uses suction to remove stone debris, and the LithoVue Elite single-use digital flexible ureteroscope, which adds real-time fluid temperature monitoring. The company also received clearance for an expanded size offering of its SEISMIQ intravascular lithotripsy catheter for treating severely calcified peripheral artery disease. In Q2, Boston Scientific reported initiation of a restructuring plan, for which it expects to make headcount reductions. Add Mpo Mag as a preferred source on Google. Get the latest Medical Product Outsourcing news, insights and analysis in your Google Search and AI experiences.
Heartflow hauls a second rival into court over cardiac CT software. The FFR-CT pioneer alleges Elucid stole trade secrets and infringed patents, months after suing Cleerly on similar grounds. Published: October 27, 2026 Heartflow sued Elucid on October 22, alleging patent infringement and trade secret theft in the market for AI analysis of coronary CT angiography. It is the second such suit this year. Heartflow went after Cleerly in April on similar grounds, claiming the rival used insider knowledge to build competing plaque analysis software. The Elucid complaint leans on four patents, including No. 9,770,303. At the centre of the case is a regulatory detail: when Elucid filed its 510(k) for FFR-IQ, it named Heartflow's FFRct as the sole predicate device and described its indications as "same as predicate." The regulator as evidence. Predicate-based clearance is routine at the FDA, and naming a competitor's product is not itself wrongdoing. But Heartflow is using the filing to argue that Elucid defined its own device by reference to Heartflow's, which makes the infringement claim easier to tell to a jury than a pure software patent fight. Elucid chief executive Kelly Huang said the Boston company is confident in the independent development of its technology and has spent over a decade building an intellectual property portfolio. It will defend the claims through the courts. What is really at stake. Software patents are notoriously hard to enforce, so the trade secret count may carry more weight than the patent claims. A Heartflow win would hand it effective control of a segment where several well-funded companies now compete. Neither company has disclosed damages sought. No trial date has been set.
Simply Wall St has named three small-cap AI stocks to watch in October 2026, as financiers warn that high valuations and concentrated AI exposure could feed the next market downturn. CeriBell, a Sunnyvale medtech company, uses AI to detect seizures from brainwave data. It generated about $102 million from diagnostic kits and equipment, all in the US, and has a market value of roughly $1.0 billion. HeartFlow turns coronary CT scans into AI-based decision tools for cardiologists. It posted about $212 million in revenue and has a market value of roughly $4.9 billion. Its Plaque Analysis moves to a Category 1 CPT code in 2026, with defined Medicare payment rates. Penguin Solutions supplies AI infrastructure. Its Integrated Memory unit brought in about $924 million, Advanced Computing about $559 million, and Optimized LED about $249 million. Its market value is near $3.2 billion.
HeartFlow CEO John C.M. Farquhar sold 38,900 shares of common stock for $1.8 million, according to a 14 September 2026 SEC filing. The shares were sold at a weighted average price of $46.78, with individual trades ranging from $45.43 to $47.78. The transaction was conducted under a Rule 10b5-1 trading plan established on 12 September 2025. Following the sale, Farquhar retains approximately 322,000 shares, representing 0.37% of the company, plus derivative securities. HeartFlow develops AI-powered cardiac diagnostic solutions that create three-dimensional digital replicas of patient hearts from CT scans. The company has a market capitalisation of $4.3 billion and generated $212.1 million in trailing 12-month revenue, whilst recording a net loss of $118.4 million.
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Industries
Company Size
501-1,000
Company Stage
IPO
Headquarters
San Francisco, CA
Founded
2010
Find jobs on Simplify and start your career today
Don't see your dream role? Check out thousands of other roles on Simplify.Browse all jobs