Heartflow Plaque Analysis to be Covered by UnitedHealthcare Plans Nationwide
Heartflow (NYSE:HTFL) announced that UnitedHealthcare, the largest commercial insurer in the United States, will provide nationwide coverage for its AI-enabled Heartflow Plaque Analysis across all business lines. The coverage, effective October 1, 2025, will include Commercial, Medicare Advantage, and Community plans.
The FDA-cleared technology, showing 95% agreement with gold standard IVUS, helps diagnose and manage coronary artery disease (CAD). Clinical outcomes from the DECIDE registry demonstrated that management changes guided by Heartflow Plaque Analysis resulted in an average LDL cholesterol decrease of 18.7mg/dL, associated with a 15% reduction in cardiac event risk.
Heartflow (NYSE:HTFL) ha annunciato che UnitedHealthcare, il più grande assicuratore commerciale negli Stati Uniti, offrirà copertura a livello nazionale per la sua analisi delle placche Heartflow abilitata dall'IA in tutte le linee di business. La copertura, valida a partire dal 1° ottobre 2025, includerà piani Commerciali, Medicare Advantage e Community.
Questa tecnologia approvata dalla FDA, che mostra un 95% di concordanza con il gold standard IVUS, aiuta nella diagnosi e gestione della malattia coronarica (CAD). I risultati clinici del registro DECIDE hanno dimostrato che i cambiamenti nella gestione guidati dall’analisi delle placche Heartflow hanno portato a una riduzione media del colesterolo LDL di 18,7 mg/dL, associata a una diminuzione del 15% del rischio di eventi cardiaci.
Heartflow (NYSE:HTFL) anunció que UnitedHealthcare, el mayor asegurador comercial en Estados Unidos, ofrecerá cobertura nacional para su Análisis de Placas Heartflow habilitado por IA en todas sus líneas de negocio. La cobertura, que entrará en vigor el 1 de octubre de 2025, incluirá planes Comerciales, Medicare Advantage y Comunitarios.
La tecnología aprobada por la FDA, que muestra un 95% de concordancia con el estándar de oro IVUS, ayuda a diagnosticar y manejar la enfermedad arterial coronaria (EAC). Los resultados clínicos del registro DECIDE demostraron que los cambios en el manejo guiados por el Análisis de Placas Heartflow resultaron en una disminución promedio de 18.7 mg/dL de colesterol LDL, asociada con una reducción del 15% en el riesgo de eventos cardíacos.
Heartflow (NYSE:HTFL)는 미국 최대 상업 보험사인 UnitedHealthcare가 자사의 AI 기반 Heartflow 플라크 분석에 대해 모든 사업 부문에서 전국적인 보장을 제공할 것이라고 발표했습니다. 이 보장은 2025년 10월 1일부터 시행되며, 상업용, 메디케어 어드밴티지 및 커뮤니티 플랜을 포함합니다.
FDA 승인 기술로, 골드 스탠다드 IVUS와 95% 일치를 보이며 관상동맥질환(CAD)의 진단 및 관리를 돕습니다. DECIDE 등록 연구의 임상 결과에 따르면 Heartflow 플라크 분석에 따른 관리 변화는 평균 LDL 콜레스테롤 18.7mg/dL 감소를 가져왔으며, 이는 심장 사건 위험 15% 감소와 연관이 있습니다.
Heartflow (NYSE:HTFL) a annoncé que UnitedHealthcare, le plus grand assureur commercial aux États-Unis, offrira une couverture nationale pour son analyse des plaques Heartflow assistée par IA dans toutes ses branches d’activité. Cette couverture, effective à partir du 1er octobre 2025, inclura les plans commerciaux, Medicare Advantage et communautaires.
Cette technologie approuvée par la FDA, affichant une concordance de 95% avec la référence IVUS, aide au diagnostic et à la gestion de la maladie coronarienne (CAD). Les résultats cliniques du registre DECIDE ont démontré que les modifications de prise en charge guidées par l’analyse des plaques Heartflow ont entraîné une diminution moyenne du cholestérol LDL de 18,7 mg/dL, associée à une réduction de 15% du risque d’événements cardiaques.
Heartflow (NYSE:HTFL) gab bekannt, dass UnitedHealthcare, der größte kommerzielle Versicherer in den USA, landesweit eine Deckung für seine KI-gestützte Heartflow Plaque-Analyse über alle Geschäftsbereiche hinweg anbieten wird. Die Deckung gilt ab dem 1. Oktober 2025 und umfasst Commercial-, Medicare Advantage- und Community-Pläne.
Die von der FDA zugelassene Technologie, die eine 95% Übereinstimmung mit dem Goldstandard IVUS aufweist, unterstützt die Diagnose und Behandlung der koronaren Herzkrankheit (KHK). Klinische Ergebnisse aus dem DECIDE-Register zeigten, dass durch die mit der Heartflow Plaque-Analyse gesteuerten Behandlungsänderungen ein durchschnittlicher LDL-Cholesterin-Abfall von 18,7 mg/dL erreicht wurde, was mit einer 15%igen Reduktion des Risikos für kardiale Ereignisse verbunden ist.
- Coverage approval from UnitedHealthcare, the largest U.S. commercial insurer
- 95% agreement with gold standard IVUS in clinical trials
- Technology changes medical management in over 50% of patients beyond CCTA alone
- Clinical data shows 18.7mg/dL reduction in LDL cholesterol, leading to 15% decrease in cardiac event risk
- Strong market presence with adoption by over 1,400 institutions globally
- None.
Insights
UnitedHealthcare's coverage of Heartflow Plaque Analysis is a major revenue catalyst that significantly expands market access for this AI coronary disease diagnostic.
This coverage decision by UnitedHealthcare represents a significant commercial breakthrough for Heartflow. As the largest US commercial insurer, UnitedHealthcare's approval across all business lines (Commercial, Medicare Advantage, and Community plans) dramatically expands the addressable market for Heartflow's AI-enabled coronary plaque analysis technology.
The October 1, 2025 effective date establishes a clear timeline for expected revenue acceleration. This coverage decision is particularly valuable as it applies to patients with 1-70% stenosis found on CCTA, capturing a broad segment of coronary artery disease patients who will now have insurance-covered access to this diagnostic tool.
The clinical validation is compelling – Heartflow Plaque Analysis demonstrates 95% agreement with IVUS (the gold standard) and has shown the ability to change medical management in over 50% of patients beyond CCTA alone. The DECIDE registry data showing an 18.7mg/dL reduction in LDL cholesterol translates to an estimated 15% decrease in cardiac event risk, establishing clear clinical utility metrics.
With CAD causing one heart attack every 40 seconds in the US and being responsible for one in five deaths, the addressable market is substantial. Heartflow's existing footprint in 1,400+ institutions globally provides the infrastructure to rapidly capitalize on this expanded coverage.
This reimbursement win significantly de-risks Heartflow's commercialization path and should accelerate adoption across UnitedHealthcare's massive network, likely prompting other major insurers to follow suit with similar coverage decisions.
Largest commercial insurer in the United States releases positive comprehensive coverage for AI-enabled Heartflow Plaque Analysis to support precise diagnosis and management of patients
MOUNTAIN VIEW, Calif., July 22, 2025 (GLOBE NEWSWIRE) -- Heartflow, Inc., the leader in AI technology for coronary artery disease (CAD), today announced Heartflow Plaque Analysis will be covered by UnitedHealthcare across all lines of business, including Commercial, Medicare Advantage, and Community plans. UnitedHealthcare is the first insurer to update its policies to cover Heartflow Plaque Analysis to fully align with the guidelines recently issued by radiology benefit manager EviCore.
“UnitedHealthcare’s decision to cover Heartflow Plaque Analysis nationwide is a tremendous step in advancing patient access to our proven AI-driven plaque technology,” said John Farquhar, President and CEO of Heartflow. “We are pleased that this major commercial payer recognizes the innovation and value that Heartflow’s technology can provide to its members and healthcare providers in diagnosing and managing coronary artery disease. This decision will increase access for early detection and quantification of plaque using our precision Plaque Analysis tool, setting a new standard for cardiovascular care coverage.”
The updated coverage will become effective October 1, 2025 for patients with acute or stable chest pain and mild-to-moderate narrowing of coronary arteries (1
Heartflow Plaque Analysis is the only FDA-cleared, AI-enabled, noninvasive plaque quantification tool with a reported
This coverage milestone follows the recent presentation of clinical outcomes from the DECIDE registry, which found management changes informed by Heartflow Plaque Analysis led to an average LDL cholesterol decrease of 18.7mg/dL.3 This clinically significant reduction is associated with an estimated
Heartflow is dedicated to transforming CAD from the leading cause of death to a disease that can be proactively managed for life. In the United States, CAD is estimated to be responsible for one heart attack every 40 seconds and one out of every five deaths.5 Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population worldwide.
About Heartflow, Inc.
Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform — including Roadmap™ Analysis, FFRCT Analysis and Plaque Analysis — is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at www.heartflow.com.
Media Contact
Elliot Levy
elevy@heartflow.com
Investor Contact
Nick Laudico
nlaudico@heartflow.com
1 Narula et al. Prospective Deep Learning-based Quantitative Assessment of Coronary Plaque by CT Angiography Compared with Intravascular Ultrasound. EHJ 2024.
2 DECIDE Registry. Rinehart, et al., Presented at SCCT July 2025.
3 DECIDE Registry. Rinehart, et al., Presented at SCCT July 2025.
4 Collins et al. Lancet 2016. DOI: 10.1016/S0140-6736(16)31357-5
5 Centers for Disease Control and Prevention. Heart Disease Facts. https://www.cdc.gov/heart-disease/data-research/facts-stats.
FAQ
When will UnitedHealthcare begin covering Heartflow Plaque Analysis?
What are the clinical benefits of Heartflow's HTFL Plaque Analysis technology?
Which patients are eligible for Heartflow Plaque Analysis coverage under UnitedHealthcare?
How widely adopted is Heartflow's plaque analysis technology?
What makes Heartflow's HTFL Plaque Analysis unique in the market?
