Heartflow, Inc. develops AI-enabled software for non-invasive detection and management of coronary artery disease. Its updates center on the Heartflow Platform and related analyses, including Heartflow FFRCT Analysis, Heartflow Plaque Analysis and Heartflow Roadmap Analysis, which use coronary CT imaging and software-based interpretation to support cardiovascular care.
Recurring news includes quarterly results, account adoption, payer coverage and reimbursement for Plaque Analysis, clinical evidence presented at cardiology meetings, patient registries such as GAMEFILM and NAVIGATE-PCI, investor conference activity, intellectual property enforcement and additions to Heartflow’s product platform such as PCI Navigator.
Heartflow (HTFL) announced prospective DECIDE registry findings associating its Plaque Analysis with 34% fewer major cardiovascular events at one year.
The evaluation compared more than 6,000 well-matched patients receiving plaque analysis with plaque staging or coronary computed tomography angiography (CCTA) alone. The plaque-analysis group had half the heart attack rate. Major events included cardiovascular death, heart attack, revascularization or stroke. Management changed in more than 50% of patients by 90 days; 50% reached LDL cholesterol below 70 mg/dL versus 35% with CCTA alone, sustained through one year.
Separately, the GAMEFILM registry found coronary plaque in 85% of 200 retired NFL players, versus 13% with a prior coronary artery disease diagnosis. GAMEFILM has expanded to former MLB players and professional staff from sports leagues and U.S. college teams. Both studies are scheduled for presentation at AHA 2026.
Heartflow (HTFL) announced that the randomized P4 trial met its primary endpoint, supporting CT-guided planning for percutaneous coronary intervention (PCI).
The 1,105-patient trial found CT-guided planning non-inferior to intravascular ultrasound (IVUS), imaging performed inside blood vessels. Twelve-month target-vessel failure was 4.1% versus 4.6%. Median procedure time was 46 versus 63 minutes, and median contrast volume was 150 versus 170 mL. P4 used Heartflow FFRCT Analysis and Heartflow Planner, an earlier version of PCI Navigator.
In the separate 203-patient NAVIGATE-PCI registry, physicians modified treatment plans in approximately 70% of patients after reviewing PCI Navigator, compared with angiography alone. Changes included stent length in 41% and lesion preparation technique in 12%. Physicians also reported higher confidence in Navigator-based plans.
Boston Scientific (BSX) reported third-quarter 2026 net sales of $5.138 billion, up 1.5 percent from the prior-year quarter. GAAP net income attributable to common stockholders fell to $582 million, or $0.40 per share, from $755 million, or $0.51 per share. Adjusted earnings per share fell to $0.73 from $0.75. MedSurg sales rose 0.6 percent and Cardiovascular sales rose 1.9 percent on a reported basis.
The company expects full-year reported sales growth of approximately 4.25 percent and adjusted earnings per share of $3.16 to $3.18. For the fourth quarter, it expects reported and organic sales declines of approximately 3.0 to 1.0 percent and adjusted earnings per share of $0.77 to $0.79. Boston Scientific also began enrollment in the Elite AF trial and received FDA clearances for two StoneSmart technologies and expanded SEISMIQ catheter sizes.
Heartflow (Nasdaq: HTFL) will release its third-quarter 2026 financial results after market close on November 12, 2026. Management will discuss the results on a conference call at 1:30 p.m. PT / 4:30 p.m. ET that day.
A live webcast will be available through Heartflow’s investor relations website, with an archived version available for 12 months after the call.
Heartflow (Nasdaq: HTFL) reported one-year results from the independent, government-funded randomized FUSION trial, presented as Late-Breaking Science at ESC 2026 and published in JACC. In 528 patients with stable chest pain, adding Heartflow FFRCT Analysis to standard CCTA reduced unnecessary invasive coronary angiography (ICA) by 44% versus CCTA alone (22% vs. 39%; p < 0.001).
Overall ICA rates at one year were lower with the Heartflow pathway (43% vs. 61%; p < 0.001), while coronary revascularization rates were identical (20% vs. 20%; p = 0.948) and major safety outcomes, including MACE, ICA complications, and stroke, did not differ significantly between groups. According to Heartflow, FUSION is the first randomized trial to test FFRCT immediately after CCTA-documented obstructive stenosis, supporting broader clinical integration of its AI-based, noninvasive CT-FFR technology.
Heartflow (Nasdaq: HTFL) announced that its management will participate in a fireside chat at the Wells Fargo 21st Annual Healthcare Conference in Boston on September 9, 2026, at 3:45 p.m. ET. A live and archived webcast will be available in the Investor Relations section of Heartflow’s website. The company will also highlight its AI-based Heartflow One platform for coronary artery disease diagnosis and management.
Heartflow (Nasdaq: HTFL) reported second quarter 2026 revenue of $64.1 million, up 48% year-over-year, driven mainly by higher U.S. FFRCT and Plaque case volumes. U.S. revenue rose to $59.6 million (+51%), while international revenue reached $4.5 million (+12%). GAAP gross margin expanded to 83.0% from 75.5%, with non-GAAP gross margin at 83.3%. Total operating expenses were $71.1 million (111% of revenue), leading to a GAAP operating loss of $17.9 million and a non-GAAP operating loss of $7.9 million. Net loss was $15.7 million (‑$0.18 per share), while non-GAAP net loss improved to $5.8 million (‑$0.07 per share). Adjusted EBITDA was ‑$6.7 million, and cash, cash equivalents and investments totaled $246.8 million as of June 30, 2026.
Heartflow raised its full‑year 2026 revenue guidance to $246–$250 million (40–42% growth) and now expects non‑GAAP gross margin of approximately 82%.
Heartflow (Nasdaq: HTFL) will release its second quarter 2026 financial results after market close on Thursday, August 13, 2026. Management will hold a conference call at 1:30 p.m. PT / 4:30 p.m. ET the same day, with access via online registration to receive dial-in details and a unique PIN.
A live and archived webcast will be available in the Investor Relations section of Heartflow’s website, with the replay accessible for 12 months. Heartflow highlights its AI-based coronary artery disease solutions, built on more than 200 million annotated CTA images, adoption at over 1,800 institutions, and clinical evidence from over 625 peer-reviewed publications and 200 studies covering more than 365,000 patients.
Heartflow (Nasdaq: HTFL) reported new clinical data at SCCT 2026 supporting its AI-based Plaque Analysis and newly launched Plaque Staging tool, now included with every analysis.
Studies in over 36,000 patients highlight risk reclassification beyond calcium scoring, high reproducibility for longitudinal tracking, and analytical consistency across conventional and photon-counting CT scanners.
Heartflow (Nasdaq: HTFL) reported Q1 2026 revenue of $52.6 million, up 41% year-over-year, with gross margin of 80.2% and non-GAAP gross margin of 80.5%.
Net loss was $27.4 million ($0.32 per share), and cash, cash equivalents and investments totaled $254.9 million. Operating expenses rose to $71.7 million, including a $7.5 million non-cash impairment from facilities optimization and headquarters relocation. Full-year 2026 revenue guidance increased to $228–$232 million (29%–32% growth) and non-GAAP gross margin guidance to about 81%.