Heartflow Announces FDA 510(k) Clearance and Launch of Next Generation Heartflow Plaque Analysis Platform
Heartflow (NASDAQ: HTFL) has achieved a significant milestone with FDA 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm. The AI-powered platform demonstrates 95% agreement with IVUS gold standard and shows a 21% improvement in plaque detection compared to its first-generation algorithm.
The enhanced platform features an advanced 3D color-coded visualization system and an expanded nomogram powered by data from 273,000 patients. Additionally, Cigna will provide nationwide coverage for Heartflow Plaque Analysis across all its business lines starting October 2025, becoming the second major insurer after UnitedHealthcare to align with EviCore guidelines.
The DECIDE Registry data revealed that Heartflow Plaque Analysis led to medical management changes in over 50% of patients and an expected 15% reduction in cardiac events.
Heartflow (NYSE: HTFL) ha raggiunto una tappa di rilievo con l’approvazione FDA 510(k) per l’algoritmo Next Gen Heartflow Plaque Analysis. La piattaforma alimentata dall’AI mostra un accordo del 95% con lo standard d’oro IVUS e registra un miglioramento del 21% nel rilevamento della placca rispetto alla sua prima generazione.
La piattaforma avanzata presenta un sistema di visualizzazione 3D codificato per colori all’avanguardia e un nomogramma ampliato alimentato dai dati di 273.000 pazienti. Inoltre, Cigna offrirà copertura nazionale per Heartflow Plaque Analysis su tutte le sue linee di attività a partire da ottobre 2025, diventando il secondo grande assicuratore dopo UnitedHealthcare ad allinearsi alle linee guida di EviCore.
I dati del DECIDE Registry hanno rivelato che Heartflow Plaque Analysis ha portato cambiamenti nella gestione medica in oltre il 50% dei pazienti e una prevista riduzione del 15% degli eventi cardiaci.
Heartflow (NASDAQ: HTFL) ha logrado un hito importante con la aprobación FDA 510(k) para su algoritmo Next Gen Heartflow Plaque Analysis. La plataforma impulsada por IA demuestra un acuerdo del 95% con el estándar de oro IVUS y muestra una mejora del 21% en la detección de la placa en comparación con su algoritmo de primera generación.
La plataforma mejorada cuenta con un sistema de visualización 3D codificado por colores de última generación y un nomograma ampliado impulsado por datos de 273,000 pacientes. Además, Cigna proporcionará cobertura nacional para Heartflow Plaque Analysis en todas sus líneas de negocio a partir de octubre de 2025, convirtiéndose en la segunda aseguradora principal tras UnitedHealthcare en alinearse con las directrices de EviCore.
Los datos del DECIDE Registry revelaron que Heartflow Plaque Analysis produjo cambios en la gestión médica en más del 50% de los pacientes y se espera una reducción del 15% de los eventos cardíacos.
Heartflow (NASDAQ: HTFL)은 FDA 510(k) 승인을 얻어 Next Gen Heartflow Plaque Analysis 알고리즘으로 중요한 이정표를 달성했습니다. AI 기반 플랫폼은 IVUS 골드 스탠다드와 95% 일치를 보이며, 첫 세대 알고리즘에 비해 플라크 탐지에서 21% 개선을 보입니다.
향상된 플랫폼은 최첨단 3D 컬러 인코딩 시각화 시스템과 273,000명 환자의 데이터를 기반으로 확장된 노모그램을 제공합니다. 또한 Cigna은 2025년 10월부터 모든 비즈니스 라인에서 Heartflow Plaque Analysis에 대한 전국적 커버리지를 제공하며, EviCore 가이드라인에 맞춘 두 번째 주요 보험사가 됩니다(UnitedHealthcare에 이은 두 번째).
DECIDE Registry 데이터에 따르면 Heartflow Plaque Analysis는 환자의 의료 관리에 변화가 나타난 비율이 50% 이상이며, 심장 사건이 15% 감소할 것으로 예상됩니다.
Heartflow (NASDAQ : HTFL) a franchi une étape majeure en obtenant l’autorisation FDA 510(k) pour son algorithme Next Gen Heartflow Plaque Analysis. La plateforme alimentée par l’IA présente un accord à 95 % avec le standard d’or IVUS et montre une amélioration de 21 % dans la détection des plaques par rapport à son algorithme de première génération.
La plateforme améliorée dispose d’un système de visualisation 3D codé par couleur de pointe et d’un nomogramme élargi alimenté par les données de 273 000 patients. De plus, Cigna offrira une couverture nationale pour Heartflow Plaque Analysis sur toutes ses lignes de métier à partir d’octobre 2025, devenant le deuxième grand assureur après UnitedHealthcare à s’aligner sur les directives d’EviCore.
Les données du DECIDE Registry ont révélé que Heartflow Plaque Analysis a entraîné des changements dans la prise en charge médicale chez plus de 50 % des patients et une réduction attendue de 15 % des événements cardiaques.
Heartflow (NASDAQ: HTFL) hat einen bedeutenden Meilenstein erreicht: die FDA 510(k)-Zulassung für seinen Next Gen Heartflow Plaque Analysis-Algorithmus. Die KI-gestützte Plattform zeigt eine 95%ige Übereinstimmung mit dem IVUS-Goldstandard und verzeichnet eine 21%-ige Verbesserung bei der Plaque-Erkennung im Vergleich zu ihrem ersten Generation-Algorithmus.
Die verbesserte Plattform verfügt über ein fortschrittliches 3D-farbkodiertes Visualisierungssystem und ein erweitertes Nomogramm, gespeist von Daten von 273.000 Patienten. Außerdem wird Cigna ab Oktober 2025 landesweit Across all its Geschäftsbereiche Heartflow Plaque Analysis abdecken und damit der zweite große Versicherer nach UnitedHealthcare, der sich an die Richtlinien von EviCore anpasst.
Die DECIDE Registry-Daten zeigten, dass Heartflow Plaque Analysis Änderungen im medizinischen Management bei über 50% der Patienten bewirkte und eine erwartete Reduzierung kardiovaskulärer Ereignisse um 15% erfahrbar ist.
Heartflow (بورصة ناسداك: HTFL) حققت علامة مهمة بصدور موافقة FDA 510(k) على خوارزمية التحليل Plaque Analysis من الجيل القادم من Heartflow. المنصة المدعومة بالذكاء الاصطناعي تُظهر اتفاقاً بنسبة 95% مع معيار IVUS الذهبي وتُظهر تحسناً بنسبة 21% في اكتشاف اللويحة مقارنةً بالجيل الأول من الخوارزمية.
تتميز المنصة المحسّنة بنظام تصور ثلاثي الأبعاد ملون متقدم ونموذج تناظري موسّع يعتمد على بيانات من 273,000 مريض. بالإضافة إلى ذلك، ستوفر سيغنا تغطية وطنية لـ Heartflow Plaque Analysis عبر جميع خطوط أعمالها اعتباراً من أكتوبر 2025، لتصبح ثاني مُؤمّن رئيسي بعد UnitedHealthcare يتماشون مع إرشادات EviCore.
أظهرت بيانات سجل DECIDE أن Heartflow Plaque Analysis أدى إلى تغيّرات في الإدارة الطبية لأكثر من 50% من المرضى وتوقع انخفاضاً بنسبة 15% في الأحداث القلبية.
Heartflow（纳斯达克股票代码：HTFL） 已取得FDA 510(k)批准，用于其Next Gen Heartflow Plaque Analysis算法，标志着一个重要里程碑。该AI驱动平台与IVUS金标准的一致性达到95%，相比第一代算法在斑块检测方面提升了21%。
升级后的平台具备先进的3D彩色可视化系统和以 27.3万名患者为数据支撑的扩展式诺模图。同时，Cigna 将于2025年10月起在其所有业务线为 Heartflow Plaque Analysis 提供全国覆盖，成为在与 EviCore 指南保持一致方面仅次于 UnitedHealthcare 的第二大保险公司。
DECIDE Registry数据显示，Heartflow Plaque Analysis 在<0b>超过50% 的患者中引发了医疗管理变革，并且预计将实现心脏事件减少15%。
- FDA 510(k) clearance received for Next Gen Heartflow Plaque Analysis algorithm
- 95% agreement with gold standard IVUS and 21% improvement in plaque detection
- Cigna to provide nationwide coverage across all business lines
- Platform led to medical management changes in over 50% of patients with 15% expected event reduction
- Expanded nomogram powered by data from 273,000 patients - 9x larger than any current study
- None.
Insights
Heartflow's FDA clearance and Cigna coverage for its advanced plaque analysis platform significantly expands market access and revenue potential.
Heartflow's FDA 510(k) clearance for its Next Gen Plaque Analysis platform represents a significant advancement in AI-powered coronary artery disease (CAD) diagnostics. The technology delivers 95% agreement with invasive ultrasound (IVUS), the gold standard for plaque assessment, while providing a 21% improvement in plaque detection compared to their first-generation algorithm.
The platform's enhanced capabilities—including advanced 3D visualization and expanded nomogram based on ~273,000 patients (9x larger than competing studies)—position Heartflow as the technological leader in non-invasive coronary plaque assessment. This matters because accurate plaque characterization is crucial for risk stratification and treatment planning in CAD patients.
Even more significant is Cigna's decision to cover Heartflow Plaque Analysis nationwide across all business lines starting October 2025. This follows UnitedHealthcare's similar coverage decision, meaning Heartflow now has reimbursement agreements with two major national insurers. The coverage applies to patients with acute or stable chest pain and mild-to-moderate coronary artery stenosis (1-69%)—a substantial addressable patient population.
The DECIDE Registry data showing that Heartflow Plaque Analysis changed medical management in over 50% of patients beyond coronary CTA alone, with an expected ~15% event reduction, provides strong clinical validation. This demonstrates both clinical utility and potential for significant healthcare cost reduction through optimized patient management and prevented adverse cardiovascular events.
This FDA clearance and Cigna coverage decision creates a substantial revenue opportunity for Heartflow. The nationwide coverage by Cigna—the second major insurer after UnitedHealthcare to cover Heartflow Plaque Analysis—significantly expands the company's addressable market and potential reimbursement streams.
The coverage pathway is clearly defined: patients with acute or stable chest pain and mild-to-moderate coronary artery stenosis (1-69%) identified on coronary CTA. This patient population represents a large segment of cardiology care, particularly as coronary CTA usage continues to increase in clinical practice.
The DECIDE Registry data showing medical management changes in over 50% of patients provides compelling economic value evidence that likely influenced Cigna's coverage decision. By demonstrating a projected ~15% reduction in cardiac events, Heartflow can position its technology as both clinically beneficial and cost-effective—a crucial combination for continued reimbursement expansion.
The technical improvements in the Next Gen platform—particularly the 21% improvement in plaque detection—strengthen Heartflow's competitive moat. The expanded nomogram derived from ~273,000 patients creates significant data network effects that competitors will struggle to match.
With FDA clearance secured and major insurance coverage expanding, Heartflow is positioning itself for accelerated adoption. The company's focus on creating a comprehensive solution that addresses both anatomical (plaque) and functional (FFRCT) aspects of coronary disease creates multiple value streams and potential expansion pathways in the cardiovascular care market.
AI-Powered Heartflow Plaque Analysis to be Covered by Cigna Health Plans Nationwide
MOUNTAIN VIEW, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm and the platform is now available. The technology features an updated algorithm, vastly expanded nomogram, and advanced 3D color-coded visualization of plaque type, volume, and distribution, empowering clinicians with the insights needed to make confident care decisions with ease. Heartflow also announced that Heartflow Plaque Analysis will be covered by Cigna across all of its lines of business, including Commercial and Medicare Advantage plans, beginning in October.
Advanced Heartflow Plaque Analysis Platform Provides Clarity in 3D
Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque quantification tool with a reported
“Understanding not only how much plaque is present, but also plaque type and distribution, is critical in predicting patient risk and guiding personalized treatment,” said Matthew Budoff, M.D., Professor of Medicine at the David Geffen School of Medicine at the University of California Los Angeles (UCLA) Medical Center. “With these enhanced capabilities, Heartflow Plaque Analysis provides clinicians with the clarity we need to move from detection to decision with speed and confidence.”
Leveraging enhanced AI, this new Plaque Analysis update marks the most sophisticated iteration of Heartflow’s technology. It provides clinicians with an intuitive visual representation of plaque types, enabling rapid assessment of CAD location and severity. Heartflow’s enhanced nomogram is powered by data from ~273,000 patients—a dataset 9x larger than any current plaque quantification study.3
Cigna Adds Nationwide Coverage for Heartflow Plaque Analysis
Cigna is the second national insurer to update its policies to cover Heartflow Plaque Analysis to fully align with the guidelines issued by radiology benefit manager EviCore, following a similar decision by UnitedHealthcare. The updated coverage will become effective on October 1, 2025 for Cigna patients with acute or stable chest pain and mild-to-moderate narrowing of coronary arteries (1
“Heartflow is proud to lead the way in coronary plaque analysis with our Next Gen platform, delivering the most representative visualization and context available for assessing patients’ disease and risk. Cigna’s decision to cover Heartflow Plaque Analysis is a testament to the power of our technology to positively impact care for its members across the United States,” said John Farquhar, President and CEO of Heartflow. “Heartflow Analyses give clinicians a view of coronary plaque by type and impact on blood flow with FFRCT that’s key to informing management strategies. These latest advancements build on Heartflow’s record of proven innovation, leveraging clinical rigor and the world’s largest dataset of coronary CTA images to continually improve our technology for clinicians and patients.”
Heartflow’s continued advancement of plaque analysis technology follows the company’s recent unveiling of the landmark DECIDE Registry data, which showed Heartflow Plaque Analysis led to medical management change in over
About Heartflow, Inc.
Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinicians with actionable insights into plaque volume and composition and its impact on blood flow – without the need for invasive procedures. Supported by ACC/AHA guidelines and more than 600 peer-reviewed publications, Heartflow has helped clinicians manage nearly 500,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at heartflow.com.
1 Ihdayhid A, et al. Radiol Cardiothorac Imaging. 2024. doi: 10.1148/ryct.230312 and internal bridging study with ICC correlation between first generation and second generation Plaque Analysis algorithm.
2 U.S. Food and Drug Administration. 510(k) Premarket Notification: K250902. https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250902.pdf
3 Tzimas, et al., Presentation SCCT July 2025.
4 DECIDE Registry. Rinehart, et al., Presented at SCCT July 2025.
5 Collins et al. Lancet 2016. DOI: 10.1016/S0140-6736(16)31357-5
Media Contact
Elliot Levy
elevy@heartflow.com
Investor Contact
Nick Laudico
nlaudico@heartflow.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5f268838-f806-4612-995b-af3aa4676cc0
FAQ
What are the key features of Heartflow's FDA-cleared Next Gen Plaque Analysis platform?
When will Cigna begin coverage for Heartflow's Plaque Analysis?
What is the accuracy rate of Heartflow's Plaque Analysis compared to IVUS?
What clinical benefits were demonstrated in the DECIDE Registry for HTFL's Plaque Analysis?
Which patients will be eligible for Cigna coverage of Heartflow Plaque Analysis?
