HEARTguide

JSON twin: https://www.healthaidb.com/software/heartguide.json

Company Name

FEops

Product URL

https://www.feops.com/heartguide

Company URL

https://www.feops.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

Summary

FEops HEARTguide is a cloud-based pre-operative planning software that utilizes digital twin technology to assist physicians in selecting optimal device sizes and positions for left atrial appendage occlusion procedures.

Description

FEops HEARTguide is a cloud-based procedure planning solution that leverages digital twin technology to provide clinicians with insights into the interaction between transcatheter structural heart devices and specific patient anatomy pre-operatively. It enables physicians to virtually model clinical scenarios with different implant positions and sizes of FDA-cleared left atrial appendage occlusion devices, aiding in the selection of the optimal size and position for each patient. The software has received FDA clearance for use with Abbott's Amplatzer Amulet and Boston Scientific's Watchman FLX devices in the United States, and is also available in the European Union, United Kingdom, Canada, and Australia for transcatheter aortic valve interventions and left atrial appendage occlusion procedures. Clinical evidence from the PREDICT-LAA trial has demonstrated that FEops HEARTguide significantly improves procedural efficiency and outcomes compared to standard CT-based planning.

Api Available

unknown

Certifications

• FDA 510(k)
• FDA De Novo

Company Founding

2017

Company Offices

• Belgium

Compliance

• FDA 510(k) clearance
• FDA De Novo clearance

Customers

Data Residency

US and EU regions

Data Standards

• DICOM

Deployment Model

• SaaS

Features

• Cloud-based procedure planning
• Digital twin technology
• Pre-operative planning for left atrial appendage occlusion (LAAo)
• Anatomical analysis of multislice CT images
• Predictive simulations for device interaction with patient anatomy
• AI-based anatomic measurements
• Virtual modeling of implant positions and sizes
• Optimized device size and position selection
• Improved procedural efficiency
• FDA clearance for LAAo planning with Abbott's Amplatzer Amulet and Boston Scientific's Watchman FLX devices
• Clinical evidence from PREDICT-LAA trial
• Integration with DICOM interface for visualization and editing of anatomical measurements

Id

SW0347

Integration Partners

Integrations

• Abbott's Amplatzer Amulet
• Boston Scientific's Watchman FLX
• DICOM interface

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• TAVI workflow support
• LAAo workflow support in EU, UK, Canada, and Australia

Os Platforms

• Web

Pricing Details

contact vendor

Pricing Model

subscription

Privacy Features

• HIPAA compliance
• Patient data anonymization

Product Code

SW0347

Product Name

HEARTguide

Ratings

Regions Available

• United States
• European Union
• United Kingdom
• Canada
• Australia

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Data encryption in transit
• Access controls
• Audit logs

Specialties

• Cardiology

Support Channels

System Requirements

Target Users

• clinicians
• nurses
• admins

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "HEARTguide",
  "company_name": "FEops",
  "product_url": "https://www.feops.com/heartguide",
  "company_url": "https://www.feops.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0347",
  "summary": "FEops HEARTguide is a cloud-based pre-operative planning software that utilizes digital twin technology to assist physicians in selecting optimal device sizes and positions for left atrial appendage occlusion procedures.",
  "description": "FEops HEARTguide is a cloud-based procedure planning solution that leverages digital twin technology to provide clinicians with insights into the interaction between transcatheter structural heart devices and specific patient anatomy pre-operatively. It enables physicians to virtually model clinical scenarios with different implant positions and sizes of FDA-cleared left atrial appendage occlusion devices, aiding in the selection of the optimal size and position for each patient. The software has received FDA clearance for use with Abbott's Amplatzer Amulet and Boston Scientific's Watchman FLX devices in the United States, and is also available in the European Union, United Kingdom, Canada, and Australia for transcatheter aortic valve interventions and left atrial appendage occlusion procedures. Clinical evidence from the PREDICT-LAA trial has demonstrated that FEops HEARTguide significantly improves procedural efficiency and outcomes compared to standard CT-based planning.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "nurses",
    "admins"
  ],
  "specialties": [
    "Cardiology"
  ],
  "regions_available": [
    "United States",
    "European Union",
    "United Kingdom",
    "Canada",
    "Australia"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "subscription",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "Belgium"
  ],
  "company_founding": "2017",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Cloud-based procedure planning",
    "Digital twin technology",
    "Pre-operative planning for left atrial appendage occlusion (LAAo)",
    "Anatomical analysis of multislice CT images",
    "Predictive simulations for device interaction with patient anatomy",
    "AI-based anatomic measurements",
    "Virtual modeling of implant positions and sizes",
    "Optimized device size and position selection",
    "Improved procedural efficiency",
    "FDA clearance for LAAo planning with Abbott's Amplatzer Amulet and Boston Scientific's Watchman FLX devices",
    "Clinical evidence from PREDICT-LAA trial",
    "Integration with DICOM interface for visualization and editing of anatomical measurements"
  ],
  "optional_modules": [
    "TAVI workflow support",
    "LAAo workflow support in EU, UK, Canada, and Australia"
  ],
  "integrations": [
    "Abbott's Amplatzer Amulet",
    "Boston Scientific's Watchman FLX",
    "DICOM interface"
  ],
  "data_standards": [
    "DICOM"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "FDA 510(k) clearance",
    "FDA De Novo clearance"
  ],
  "certifications": [
    "FDA 510(k)",
    "FDA De Novo"
  ],
  "security_features": [
    "Data encryption in transit",
    "Access controls",
    "Audit logs"
  ],
  "privacy_features": [
    "HIPAA compliance",
    "Patient data anonymization"
  ],
  "data_residency": "US and EU regions",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0347",
  "slug": "heartguide",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/heartguide.json"
  }
}