FEops HEARTguideTM

by FEops nv  · Based in Belgium → — Altering the course of heart disease with cutting-edge, AI-based technology.
Cardiology Cardiothoracic Surgery Radiology
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Regulatory Status Disclosed

Overview

FEops HEARTguide™ is a cloud-based structural heart procedure planning platform that leverages predictive simulation technology and artificial intelligence (AI) to provide unprecedented insights into a patient’s total heart health. It analyzes cardiac computed tomography (CT) scans to deliver AI-based anatomical measurements and data that was previously inaccessible. This platform aims to improve procedure efficiency and outcomes by enabling physicians to more accurately predict how transcatheter structural heart devices will interact with a specific patient’s anatomy.

The software goes beyond traditional anatomical measurements by combining digital twins with AI-enabled anatomical analysis, offering a detailed preview of device-anatomy interaction before the procedure. It supports pre-operative planning for various structural heart interventions, including Transcatheter Aortic Valve Implantation (TAVI/TAVR) and Left Atrial Appendage Occlusion (LAAO), and is also exploring applications in Transcatheter Mitral Valve Replacement (TMVR).

FEops HEARTguide™ is designed to be a unique, stand-alone solution that delivers results easily integrated into clinical workflows. It offers a collaborative environment, allowing secure access and case sharing with peers and industry partners from anywhere at any time.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Predictive simulation technology for device-anatomy interaction
  • AI-based anatomical measurements from CT scans
  • Cloud-based platform with access from anywhere at any time
  • DICOM interface for easy integration into clinical workflow
  • Semi-automatic and manual measurement options for anatomical landmarks
  • Interactive 2D and 3D viewer for detailed analysis
  • Segmentation of cardiovascular structures
  • Visualization and image reconstruction techniques (2D review, MPR)
  • Tools for taking measurements and making annotations
  • Collaborative platform for secure case sharing with peers
  • Multi-factor authentication and enforced password changes for security
  • TAVI lifetime management with redo-TAVI options and coronary access insights

Use Cases

  • Pre-operative planning for Transcatheter Aortic Valve Implantation (TAVI/TAVR)
  • Pre-operative planning for Left Atrial Appendage Occlusion (LAAO)
  • TAVI lifetime management, including planning for future valve-in-valve procedures
  • Neo-LVOT assessment
  • Patient-specific computer simulations to assess impact of TAVI sizing and positioning
  • Accelerating research and development of novel cardiovascular devices

What Physicians Need to Know

Cardiac CT/MRI Analysis
FEops HEARTguideu2122 utilizes cardiac CT scans to perform AI-based anatomical analysis and predictive simulations for structural heart interventions. It segments cardiovascular structures, offers 2D review and Multiplanar Reconstruction (MPR) visualization, and includes semi-automatic identification and measurement of anatomical landmarks with manual control options. The platform transforms cardiac images into patient-specific 'digital twins' to predict the interaction between transcatheter devices (such as for TAVI, LAAO, and TMVR) and the patient's unique anatomy, aiding in optimal device sizing and positioning. It has received FDA clearance for its AI-based anatomical analysis capabilities.
Coronary Artery Assessment (TAVI Lifetime Management)
For Transcatheter Aortic Valve Implantation (TAVI) lifetime management, FEops HEARTguideu2122 provides insights into potential coronary access for future redo-TAVI procedures.
Physician Tip

Leverage FEops HEARTguideu2122 for comprehensive pre-procedural planning in structural heart interventions, particularly for TAVI and LAAO. The AI-driven anatomical analysis and patient-specific predictive simulations offer critical insights into device-anatomy interaction, helping to optimize device selection, size, and positioning. This can lead to improved procedural efficiency and outcomes, and potentially reduce complications like paravalvular leak and pacemaker implantation.

FEops HEARTguideu2122 is a cloud-based platform, offering secure access and collaboration from anywhere at any time. It features a DICOM interface for easy upload of patient CT scans. The platform has partnered with companies like TeraRecon for commercialization and integration of its LAA occlusion workflow into existing software solutions, streamlining pre-treatment CT-based planning for structural heart interventions.

Details

Category Cardiology AI
Pricing Contact for pricing
  • Not publicly disclosed; service-based business model where clinicians provide input data, FEops prepares analysis, and delivers results
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

FEops HEARTguide™ has received multiple FDA clearances. This includes De Novo authorization for LAAo pre-operative planning with Boston Scientific WATCHMAN™ device (October 2021), and subsequent authorization for LAAo planning with Abbott's Amplatzer™ Amulet™ and Boston Scientific's Watchman FLX™ device (April 2022). The K223855 clearance (June 6, 2023) for 'FEops HEARTguide™ ALPACA' specifically covers visualization and measurement of heart and vessel structures for preprocedural planning and sizing of structural heart interventions. Additional clearances include K214066 (Feb 2022) and K250635 (Nov 2025) for simulation applications.
Integrations
EHR Not specified
Specialties Cardiology, Cardiothoracic Surgery, Radiology

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Press & Coverage

FEops
FEops HEARTguideu2122 NEW Release
FEops announced a new release of FEops HEARTguideu2122 with innovative features for TAVI Lifetime management and LAAo interventions, including updated TAVI simulation output and expanded device libraries.
2025-09
European Heart Journal - Cardiovascular Imaging
Clinical Validation of Predictive Procedural Planning Software in a Real-World TAVI Population
This study aimed to compare aortic root measurements by GE software and FEops HEARTguideu2122 and validate FEops HEARTguideu2122's accuracy in predicting post-TAVI paravalvular aortic regurgitation and new conduction abnormalities.
2026-02
Business Wire
Clinical Utility of FEops AI-enabled Predictive Pre-planning for LAAO Demonstrated in US
Data presented at the AF Symposium 2024 showed that Left Atrial Appendage Occlusion (LAAO) procedures planned with FEops HEARTguideu2122 significantly improved procedural efficiency in a US single-center experience.
2024-02
Business Wire
FEops Receives FDA Clearance for Its AI-Based Anatomical Analysis Capabilities
FEops announced FDA clearance for its new FEops HEARTguideu2122 release, which includes AI-based anatomical analysis of MSCT images for pre-operative planning of structural heart interventions.
2023-06
Business Wire
FEops HEARTguide Proven to Significantly Enhance Efficiency and Outcomes of LAA Closure Procedures
The PREDICT-LAA study, published in JACC: Cardiovascular Interventions, demonstrated that FEops HEARTguideu2122 significantly improved procedural efficiency and outcomes for Left Atrial Appendage Closure (LAAC) procedures.
2023-02
Business Wire
FEopsu2019 AI-enabled Solution Changes TAVI Pre-procedural Decision in One Third of Patients, Associated With Favorable Clinical Outcomes
Data from the PRECISE-TAVI study showed that using FEops HEARTguideu2122 for Transcatheter Aortic Valve Implantation (TAVI) planning led to a 35% change in pre-procedural decisions, associated with favorable clinical outcomes.
2022-11
Business Wire
FEops HEARTguide Receives FDA Clearance for LAAo Planning Capabilities
FEops announced FDA authorization for FEops HEARTguideu2122 for pre-operative planning of left atrial appendage occlusion (LAAo) with Abbott's Amplatzeru2122 Amuletu2122 and Boston Scientific's Watchman FLXu2122 devices.
2022-04
Business Wire
FEops HEARTGuide Combines Digital Twins and AI to Revolutionize Structural Heart Planning
FEops integrated Artificial Intelligence into its CE marked FEops HEARTguide platform, strengthening its position as a cloud-based digital health player in structural heart.
2021-05

Videos

Product demos, reviews, and walkthroughs for FEops HEARTguideTM.

View all on YouTube

Frequently Asked Questions

FEops HEARTguideu2122 is a cloud-based platform that integrates into the TAVI workflow by using patient CT-scans to provide AI-based anatomical measurements and predictive simulations of device-anatomy interaction. This enables clinicians to select optimal device size and implant position, assess device apposition, and has been shown to change pre-procedural decisions in a significant percentage of complex TAVI cases, leading to favorable clinical outcomes such as reduced paravalvular leakage and new pacemaker implantation rates.
FEops HEARTguideu2122 holds CE Mark approval for TAVI and LAAO workflows in the EU, UK, Canada, and Australia. In the US, it has received FDA clearance for LAAO planning with specific devices (WATCHMANu2122, WATCHMANu2122 FLX, Amplatzeru2122 Amuletu2122) and for its AI-based anatomical analysis capabilities, though TAVI simulations are pending 510(k) clearance for clinical use in the US. The cloud-based platform ensures data confidentiality in line with national privacy legislation like GDPR and HIPAA, and offers security features such as multi-factor authentication and enforced password changes.
Alternatives to FEops HEARTguideu2122 include traditional pre-procedural planning methods relying on basic anatomical measurements and 'rigid-device overlay' techniques, as well as other basic computer modeling tools like 3mensioTM, Circle Cardiovascular Imaging, and Laralab. FEops HEARTguideu2122 differentiates itself by employing digital twin technology and finite element analysis (FEA) to provide patient-specific predictive simulations, offering deeper insights into how a transcatheter device will interact with unique patient anatomy and predicting tissue deformation and potential complications preoperatively.
Information regarding the typical pricing structure, specific subscription models, or different tiers for FEops HEARTguideu2122 for hospitals or individual practices is not publicly available in the provided search results.
FEops HEARTguideu2122 is not intended as a stand-alone diagnostic device and its TAVI simulations are currently pending 510(k) clearance for clinical use in the US. Studies have indicated it may underestimate aortic root dimensions compared to other software, potentially affecting prosthesis sizing in some cases, and while generally predictive at a population level, individual patient parameter overlap can occur. User expertise requires qualified clinicians to interpret outputs in conjunction with device instructions-for-use, patient history, and their professional judgment, with the user interface designed for simplicity for extensively educated end-users.
Clinical evidence for FEops HEARTguideu2122 includes the PRECISE-TAVI study, which demonstrated a 35% change in pre-procedural decisions, leading to favorable clinical outcomes and reduced complication rates like new pacemaker implantation and paravalvular leak in complex TAVI anatomies. The PREDICT-LAA study also showed improved efficiency and outcomes for Left Atrial Appendage Occlusion procedures. Furthermore, studies have validated its accuracy in predicting post-TAVI paravalvular aortic regurgitation and new conduction abnormalities, and its ability to accurately predict WATCHMAN FLX device implantation characteristics.

Compare FEops HEARTguideTM

VS
FEops HEARTguideTM vs EchoNext
Cardiology AI Adjacent · 65/100
FEops HEARTguideTM is designed for pre-procedural planning of structural heart interventions, offering predictive simulations and anatomical insights for device optimization. In contrast, EchoNext focuses on early detection of…
VS
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION vs FEops HEARTguideTM
Cardiology AI Adjacent · 60/100
Tool A, SENSICARDIAC MOBI, is designed for the diagnostic phase, assisting physicians in identifying heart murmurs by analyzing acoustic heart signals from a stethoscope. In contrast, Tool B,…
VS
SENSICARDIAC vs FEops HEARTguideTM
Cardiology AI Adjacent · 60/100
SENSICARDIAC focuses on early diagnosis by detecting and classifying heart murmurs using electronic stethoscope data. In contrast, FEops HEARTguide™ specializes in pre-procedural planning for structural heart interventions, utilizing…
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FEops HEARTguideTM vs AI-ECG Tracker
Cardiology AI Adjacent · 65/100
Tool A focuses on pre-procedural planning for structural heart interventions using CT scans and predictive simulations to optimize device placement. In contrast, Tool B specializes in AI-powered auto-diagnosis…

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More from FEops nv

FEops HEARTguide
FEops NV
Cardiology AI
FEops HEARTguide™ is a cloud-based AI and digital twin platform for structural heart procedure planning, providing predictive simulations and anatomical measurements to optimize device sizing and positioning for improved patient outcomes.
Contact for pricing

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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