Products

Heartvue.Proton
Heartvue.ai
Cardiology AI
Heartvue.ai provides AI-powered software for automating cardiac MRI analysis and optimizing echocardiography documentation and revenue.

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About Heartvue.ai

Heartvue.ai is a healthcare AI company focused on transforming cardiovascular imaging analysis. Founded by a cardiologist with over two decades of experience in advanced cardiac imaging, the company develops AI-powered tools to make advanced cardiac imaging analysis more accessible, consistent, and efficient for healthcare systems. Their mission is to alleviate the burden of manual workflows that often bottleneck cardiovascular imaging programs, leading to inconsistencies in reporting and potential revenue loss due to documentation gaps.

Heartvue.ai offers two primary products: Heartvue.Proton and Heartvue.Echo. Heartvue.Proton is an FDA 510(k) cleared AI/ML-powered platform designed for cardiac MRI automation. It automates 2D, volumetric, and flow measurements, streamlines report generation, and supports billing workflows, allowing physicians to focus more on interpretation and less on time-intensive post-processing. Heartvue.Echo focuses on echocardiography revenue optimization by identifying acquired images, supporting complete reporting, tracking documentation through the EMR, and validating reimbursement. The company aims to improve efficiency, consistency, and financial performance in cardiovascular imaging programs by reducing manual workload, improving reporting standardization, and identifying revenue gaps.

Focus Areas

cardiac MRI analysis echocardiography documentation AI-powered automation cardiovascular imaging workflow revenue optimization reporting consistency

Business Intelligence

Key InvestorsVanderbilt University (through its Center for Technology Transfer and Commercialization and Brock Family Center for Applied Innovation)
PartnershipsInnolitics (regulatory consulting), Vanderbilt University Medical Center (technology licensing, research, beta sites)
Acquisitionsunknown
Technologycloud-native, HL7 and FHIR ready, HIPAA compliant, machine learning–powered software
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

Cardiac MRI Analysis (Heartvue.Proton)
Automates 2D, volumetric, and flow measurements for cardiac MRI in seconds, reducing manual post-processing time. It generates structured reports for faster interpretation and supports billing workflow with complete documentation. Heartvue.Proton is FDA 510(k) cleared and includes an FDA-authorized Predetermined Change Control Plan (PCCP), allowing for model improvements without new 510(k) submissions.
Echocardiography Documentation (Heartvue.Echo)
Optimizes revenue by identifying acquired images, supporting complete reporting with intelligent guidance, tracking documentation through the EMR, and validating reimbursement against studies performed. It aims to surface documentation and coding gaps to improve reimbursement capture.
AI-Powered Automation
Leverages AI to eliminate repetitive manual tasks in cardiac MRI interpretation and echocardiography documentation, allowing physicians to focus on clinical synthesis and patient care.
Cardiovascular Imaging Workflow
Provides solutions to improve efficiency, reporting consistency, and financial performance across the entire cardiovascular imaging workflow, from acquisition to report to payment.
Revenue Optimization
Specifically for echocardiography, Heartvue.Echo helps identify and track documentation and coding gaps to improve reimbursement integrity and financial performance.
Reporting Consistency
Supports standardized documentation across readers and sites for both cardiac MRI and echocardiography, enhancing quality and clinical confidence.
Physician Tip

Heartvue.ai's tools are designed to amplify physician expertise, not replace it. Physicians can expect to spend significantly less time on manual post-processing and repetitive tasks, allowing them to focus on clinical interpretation, synthesis, and patient care. The structured reports and automated measurements aim to improve consistency and efficiency in daily workflows. The platform also provides visibility into documentation and reimbursement, which can help optimize the financial performance of imaging programs.

Heartvue is designed for modern clinical environments, built with HL7 and FHIR standards compliance. It integrates directly with hospital PACS and EHR systems, fitting into existing cardiology and radiology reading workflows. The architecture is cloud-first and HIPAA compliant with SOC II certification, ensuring data security with encryption in transit and at rest, and strict access controls.

Products by Heartvue.ai

1 product in the directory

Heartvue.Proton
Heartvue.ai
Cardiology AI
Heartvue.ai provides AI-powered software for automating cardiac MRI analysis and optimizing echocardiography documentation and revenue.

What the Web Says

Heartvue.ai is a company founded by cardiologists, imaging specialists, and AI engineers that develops AI-powered tools for cardiovascular imaging analysis. Their mission is to make advanced cardiac imaging analysis accessible, consistent, and efficient for health systems by automating manual workflows. Heartvue.Proton, their AI-powered cardiac MRI analysis platform, recently received FDA 510(k) clearance, which includes a Predetermined Change Control Plan (PCCP) allowing for post-market model updates without new submissions.

Overall: Positive

Strengths

  • Automates time-consuming cardiac MRI analysis, reducing manual post-processing and reporting time.
  • Aims to deliver faster analysis, more consistent reporting, and stronger financial performance for health systems.
  • Founded by cardiologists and imaging specialists, ensuring clinical relevance and understanding of clinician needs.
  • Heartvue.Proton has received FDA 510(k) clearance, including a PCCP for continuous model improvement.
  • Integrates with existing hospital PACS and EHR systems, fitting into current cardiology and radiology workflows.
  • Designed to augment rather than replace physician expertise, allowing clinicians to focus on patient care.

Limitations

  • No specific product or company reviews were found on G2, Glassdoor, Capterra, or Reddit.
  • The technology is relatively new, with FDA clearance for Heartvue.Proton announced in September 2026, so widespread user feedback may not yet be available.
  • General concerns about AI in healthcare, such as the need for real-world validation and potential for false positives, may apply, though not specifically directed at Heartvue.ai.

Based on reviews from: Heartvue.AI, Vanderbilt University, Morningstar, AuntMinnie, Innolitics, Reddit

Last updated: 2026-09-19

Videos

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Press & Coverage

Diagnostic and Interventional Cardiology
Heartvue.ai, Innolitics Achieve FDA Clearance for AI-Powered Cardiac MRI Analysis Platform
Heartvue.ai and Innolitics announced FDA 510(k) clearance for Heartvue.Proton, an AI-powered software for cardiac MRI analysis, on September 2, 2026. This platform automates time-consuming measurements, aiming to improve patient access to quantitative cardiac care.
2026-09
Business Wire
Heartvue.ai and Innolitics Achieve FDA 510(k) Clearance for Heartvue.Proton, an AI-Powered Cardiac MRI Analysis Platform
Heartvue.ai, a cardiac imaging AI company, and Innolitics, a regulatory consultancy, received FDA 510(k) clearance for Heartvue.Proton, their AI-powered cardiac MRI analysis software. The clearance includes a Predetermined Change Control Plan (PCCP), allowing for future model improvements without new 510(k) submissions.
2026-09
Medical Device Network
FDA clears Heartvue's cardiac image evaluation software
Heartvue.ai's machine learning-powered software, Heartvue.Proton, has secured US FDA clearance to streamline cardiovascular MRI evaluation. The company states that the software automates measurements across various cardiac parameters, reducing manual analysis time.
2026-09
Imaging Technology News
Heartvue.Proton Cardiac MRI Software Wins FDA Clearance on First Submission
A Tennessee startup, Heartvue.ai, received FDA 510(k) clearance for its Heartvue.Proton software, which automates cardiac MRI scan analysis. This approval, achieved on the company's first submission, aims to expand patient access to quantitative cardiac imaging by reducing manual workload.
2026-09
Vanderbilt University Medical Center
FDA Clears Cardiac Imaging Software Developed with Vanderbilt Researchers
The FDA cleared Heartvue.Proton, an AI-powered cardiac MRI platform built on technology co-developed by Vanderbilt cardiologist Jeffrey Dendy. A comparative study showed the platform reduced cardiac MRI study reading and reporting time by 7.8 times.
2026-09
Vanderbilt University
Heartvue.AI u2013 Transforming Cardiac Imaging Through AI-Powered Automation
Heartvue.AI, founded by Vanderbilt cardiologist Dr. Jeffrey Dendy, is developing AI tools to automate cardiac MRI analysis, streamline reporting, and optimize billing workflows. The company recently submitted its FDA 510(k) application, marking a significant step towards commercialization.
2026-06
AuntMinnie.com
Heartvue.ai gets FDA nod for cardiac MRI analysis software
Heartvue.ai received FDA clearance for its cardiac MRI analysis software, Heartvue.Proton, which facilitates the viewing, post-processing, and quantitative evaluation of cardiovascular MR images. This news was highlighted in an article discussing broader AI advancements in radiology.
2026-09
Innolitics
We Got a Cardiac MRI Analysis AI SaMD Cleared in 5.5 Months, PCCP Included
Innolitics details their role in helping Heartvue.ai achieve FDA 510(k) clearance for Heartvue.Proton in 5.5 months, including an FDA-authorized Predetermined Change Control Plan (PCCP). This case study highlights the regulatory journey for the AI-powered cardiac MRI analysis platform.
2026-09

Frequently Asked Questions

Heartvue.ai offers two main products: Heartvue.Proton and Heartvue.Echo. Heartvue.Proton is an AI-powered software that automates cardiac MRI measurements, streamlines reporting, and supports billing workflows. Heartvue.Echo focuses on echocardiography documentation and revenue optimization by identifying acquired images, supporting complete reporting, tracking documentation through the EMR, and validating reimbursement integrity.
Heartvue.ai's solutions automate repetitive tasks in cardiac MRI post-processing, such as 2D, volumetric, and flow measurements, allowing physicians to focus on interpretation and patient care. For both cardiac MRI and echocardiography, the platforms generate structured reports and provide guidance to support standardized documentation across different readers and sites, thereby improving consistency and reducing variation.
Heartvue.ai aims to optimize revenue by identifying documentation and coding gaps in echocardiography workflows that may lead to underpayment. Their Heartvue.Echo product tracks documentation from image acquisition through the EMR to payment, providing end-to-end visibility to ensure reimbursement matches the services performed.
Heartvue.Proton, their cardiac MRI analysis platform, has received FDA 510(k) clearance. This clearance includes a Predetermined Change Control Plan (PCCP), which allows for updates to their machine learning models within pre-specified bounds without requiring new 510(k) submissions. Heartvue.ai states that their platforms are HIPAA compliant and built with HL7 and FHIR standards for integration.
Heartvue.ai provides a dedicated implementation manager and access to a clinical success team, offering onboarding, ongoing training, and responsive technical support. Implementation, including EMR and PACS integration, typically takes 4-8 weeks. While specific pricing details are not publicly available, Heartvue.ai has partnerships with entities like Vanderbilt University and Innolitics, the latter assisting with FDA clearance.
Heartvue.ai was founded by Vanderbilt cardiologist and imaging specialist Dr. Jeffrey Dendy, along with a team of cardiologists, imaging specialists, and AI engineers. The company licensed its technology through Vanderbilt's Center for Technology Transfer and Commercialization and has received support from the Brock Family Center for Applied Innovation. They have successfully achieved FDA 510(k) clearance for Heartvue.Proton, indicating significant progress in their growth journey.

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