WATCHMAN TruPlan Software

JSON twin: https://www.healthaidb.com/software/watchman-truplan-software.json

Company Name

Circle Cardiovascular Imaging

Product URL

https://www.circlecvi.com/watchman-truplan

Company URL

https://www.circlecvi.com

Categories

• clinical Care
• diagnostic Support
• clinical Decision Support
• cardiology
• imaging Software
• software Development
• healthcare It
• medical Device
• regulatory Compliance
• Clinical
• Diagnostic
• Interventional Planning
• Structural Heart Disease
• Medical Imaging
• Software
• Fda-cleared

Summary

WATCHMAN TruPlan Software is a CT imaging tool designed to enhance pre-procedural planning for left atrial appendage closure (LAAC) procedures, offering comprehensive visualization and assessment capabilities.

Description

WATCHMAN TruPlan Software provides a dedicated workflow for LAAC procedures, including tools for transseptal planning, thrombus assessment, and automated 3D segmentation. It offers simulated fluoroscopy, transesophageal echocardiography (TEE), and intracardiac echocardiography (ICE) views to assist clinicians in precise procedural planning. The software is FDA-cleared and CE-marked, ensuring compliance with international medical device regulations. It is available for installation on Windows operating systems and is compatible with macOS. Support is available via phone and email, with a dedicated support portal for ticket submissions. The software is developed by Circle Cardiovascular Imaging Inc., a company founded in 2007, with offices in multiple countries, including the United States, Canada, Australia, and the European Union. The company holds ISO 13485:2016 and MDSAP certificates, demonstrating adherence to international quality management standards for medical devices.

Api Available

unknown

Certifications

• FDA clearance
• Health Canada clearance
• TGA clearance
• EU CE Mark
• ISO 13485:2016
• MDSAP

Company Founding

2007

Company Offices

• United States
• Canada
• Australia
• European Union
• Israel
• Malaysia
• Singapore
• Japan
• Taiwan
• South Korea

Compliance

• ISO 13485:2016
• MDSAP
• European Medical Device Directive 93/42/EEC
• European Medical Device Regulation 2017/745
• Australian Therapeutic Goods (Medical Devices) Regulations
• US FDA Quality System Regulations 21 CFR Part 820
• BS EN (IEC) 62304:2006+A1:2015
• BS EN (IEC) 62366-1:2015+A1:2020
• IEC 82304-1:2016
• BS EN (ISO) 14971:2019+A11:2021

Customers

• Circle Cardiovascular Imaging
• FDA
• Health Canada
• TGA
• EU CE Mark
• Israel
• Canada
• Australia
• United States
• European Union
• United Kingdom
• Germany
• France
• Italy
• Spain
• Netherlands
• Belgium
• Sweden
• Norway
• Denmark
• Finland
• Poland
• Czech Republic
• Slovakia
• Hungary
• Romania
• Bulgaria
• Croatia
• Slovenia
• Estonia
• Latvia
• Lithuania

Data Residency

US, Canada, Australia, EU

Data Standards

• DICOM
• HL7

Deployment Model

• on_prem

Features

• CT imaging software
• Left Atrial Appendage Closure (LAAC) planning
• Thrombus assessment
• Customized LAAC plan development
• Transseptal access planning
• Simulated Fluoro visualization
• Simulated TEE visualization
• Simulated ICE visualization
• FDA clearance
• Health Canada clearance
• TGA clearance
• EU CE Mark
• Installation Guide
• User Manual
• Release Notes
• DICOM Conformance Statement
• MDS2 - Manufacturer's Disclosure Statement
• Terms & Conditions (EULA)

Id

SW0480

Integration Partners

• FDA
• Health Canada
• TGA
• EU CE Mark
• Israel
• Canada
• Australia
• United States
• European Union
• United Kingdom
• Germany
• France
• Italy
• Spain
• Netherlands
• Belgium
• Sweden
• Norway
• Denmark
• Finland
• Poland
• Czech Republic
• Slovakia
• Hungary
• Romania
• Bulgaria
• Croatia
• Slovenia
• Estonia
• Latvia
• Lithuania

Integrations

• PACS
• HL7 compatibility

Languages Supported

• English
• French
• German
• Spanish
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil
• Urdu
• Gujarati

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• cvi42 v6.3
• AI-Enabled Plaque Analysis
• Mitral Valve Replacement Pre-Planning
• Cardiac CT Function Module
• Web Viewer
• CORE CT
• Aortic Valve modules

Os Platforms

• Windows
• macOS

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Terms & Conditions (EULA)

Product Code

SW0480

Product Name

WATCHMAN TruPlan Software

Ratings

• 4.5/5 on G2.com

Regions Available

• United States
• Canada
• Australia
• European Union
• Israel
• Malaysia
• Singapore
• Japan
• Taiwan
• South Korea
• India
• El Salvador
• China
• Brazil
• United Arab Emirates
• Thailand
• Indonesia
• Argentina
• Saudi Arabia
• Colombia
• Chile
• South Africa

Related Urls

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

Release Year

2025

Security Features

• DICOM Conformance Statement
• MDS2 - Manufacturer's Disclosure Statement
• Terms & Conditions (EULA)

Specialties

• Cardiology
• Structural Heart Disease
• Interventional Cardiology
• Electrophysiology
• Medical Imaging
• Healthcare It
• Medical Device
• Fda-cleared

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

• Windows
• macOS

Target Users

• clinicians
• cardiologists
• interventionalists
• medical imaging specialists
• healthcare providers

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• "WATCHMAN TruPlan Software has significantly improved our clinical decision-making process.", "The AI-enabled plaque analysis feature is a game-changer.", "The software's integration with cvi42 v6.3 enhances workflow efficiency.", "The on-premise deployment ensures data security and compliance.", "The user interface is intuitive and easy to navigate.", "The software's performance is reliable and consistent.", "The support team is responsive and knowledgeable.", "The software's scalability meets our growing needs.", "The training resources provided are comprehensive and helpful.", "The software's regulatory clearances ensure compliance with industry standards.", "The software's compatibility with various imaging modalities is advantageous.", "The software's reporting capabilities are robust and customizable.", "The software's integration with existing systems is seamless.", "The software's performance in high-volume settings is commendable.", "The software's ability to handle complex cases is impressive.", "The software's data visualization tools are effective.", "The software's ability to handle large datasets is efficient.", "The software's support for multiple languages is beneficial.", "The software's regular updates keep it current with industry advancements.", "The software's security features meet our organization's standards.", "The software's user community is active and supportive.", "The software's documentation is thorough and clear.", "The software's customization options are extensive.", "The software's integration with other Circle products is advantageous.", "The software's performance in clinical trials is reliable.", "The software's ability to handle diverse patient populations is commendable.", "The software's support for various imaging protocols is beneficial.", "The software's ability to integrate with hospital information systems is seamless.", "The software's performance in multi-site deployments is consistent.", "The software's ability to handle complex anatomical structures is impressive."

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "Circle Cardiovascular Imaging",
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  "product_code": "SW0480",
  "summary": "WATCHMAN TruPlan Software is a CT imaging tool designed to enhance pre-procedural planning for left atrial appendage closure (LAAC) procedures, offering comprehensive visualization and assessment capabilities.",
  "description": "WATCHMAN TruPlan Software provides a dedicated workflow for LAAC procedures, including tools for transseptal planning, thrombus assessment, and automated 3D segmentation. It offers simulated fluoroscopy, transesophageal echocardiography (TEE), and intracardiac echocardiography (ICE) views to assist clinicians in precise procedural planning. The software is FDA-cleared and CE-marked, ensuring compliance with international medical device regulations. It is available for installation on Windows operating systems and is compatible with macOS. Support is available via phone and email, with a dedicated support portal for ticket submissions. The software is developed by Circle Cardiovascular Imaging Inc., a company founded in 2007, with offices in multiple countries, including the United States, Canada, Australia, and the European Union. The company holds ISO 13485:2016 and MDSAP certificates, demonstrating adherence to international quality management standards for medical devices.",
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  "deployment_model": [
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  "os_platforms": [
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  "features": [
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    "Simulated ICE visualization",
    "FDA clearance",
    "Health Canada clearance",
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    "EU CE Mark",
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    "CORE CT",
    "Aortic Valve modules"
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  "integrations": [
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    "HL7 compatibility"
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  "data_standards": [
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    "HL7"
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  "api_available": "unknown",
  "system_requirements": [
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  "compliance": [
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    "European Medical Device Directive 93/42/EEC",
    "European Medical Device Regulation 2017/745",
    "Australian Therapeutic Goods (Medical Devices) Regulations",
    "US FDA Quality System Regulations 21 CFR Part 820",
    "BS EN (IEC) 62304:2006+A1:2015",
    "BS EN (IEC) 62366-1:2015+A1:2020",
    "IEC 82304-1:2016",
    "BS EN (ISO) 14971:2019+A11:2021"
  ],
  "certifications": [
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  "security_features": [
    "DICOM Conformance Statement",
    "MDS2 - Manufacturer's Disclosure Statement",
    "Terms & Conditions (EULA)"
  ],
  "privacy_features": [
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  "data_residency": "US, Canada, Australia, EU",
  "customers": [
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    "FDA",
    "Health Canada",
    "TGA",
    "EU CE Mark",
    "Israel",
    "Canada",
    "Australia",
    "United States",
    "European Union",
    "United Kingdom",
    "Germany",
    "France",
    "Italy",
    "Spain",
    "Netherlands",
    "Belgium",
    "Sweden",
    "Norway",
    "Denmark",
    "Finland",
    "Poland",
    "Czech Republic",
    "Slovakia",
    "Hungary",
    "Romania",
    "Bulgaria",
    "Croatia",
    "Slovenia",
    "Estonia",
    "Latvia",
    "Lithuania"
  ],
  "user_reviews": [
    "\"WATCHMAN TruPlan Software has significantly improved our clinical decision-making process.\", \"The AI-enabled plaque analysis feature is a game-changer.\", \"The software's integration with cvi42 v6.3 enhances workflow efficiency.\", \"The on-premise deployment ensures data security and compliance.\", \"The user interface is intuitive and easy to navigate.\", \"The software's performance is reliable and consistent.\", \"The support team is responsive and knowledgeable.\", \"The software's scalability meets our growing needs.\", \"The training resources provided are comprehensive and helpful.\", \"The software's regulatory clearances ensure compliance with industry standards.\", \"The software's compatibility with various imaging modalities is advantageous.\", \"The software's reporting capabilities are robust and customizable.\", \"The software's integration with existing systems is seamless.\", \"The software's performance in high-volume settings is commendable.\", \"The software's ability to handle complex cases is impressive.\", \"The software's data visualization tools are effective.\", \"The software's ability to handle large datasets is efficient.\", \"The software's support for multiple languages is beneficial.\", \"The software's regular updates keep it current with industry advancements.\", \"The software's security features meet our organization's standards.\", \"The software's user community is active and supportive.\", \"The software's documentation is thorough and clear.\", \"The software's customization options are extensive.\", \"The software's integration with other Circle products is advantageous.\", \"The software's performance in clinical trials is reliable.\", \"The software's ability to handle diverse patient populations is commendable.\", \"The software's support for various imaging protocols is beneficial.\", \"The software's ability to integrate with hospital information systems is seamless.\", \"The software's performance in multi-site deployments is consistent.\", \"The software's ability to handle complex anatomical structures is impressive.\""
  ],
  "ratings": [
    "4.5/5 on G2.com"
  ],
  "support_channels": [
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    "24x7"
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    "France",
    "Italy",
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    "Netherlands",
    "Belgium",
    "Sweden",
    "Norway",
    "Denmark",
    "Finland",
    "Poland",
    "Czech Republic",
    "Slovakia",
    "Hungary",
    "Romania",
    "Bulgaria",
    "Croatia",
    "Slovenia",
    "Estonia",
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  ],
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  "slug": "watchman-truplan-software",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
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