Products

RTHawk
HeartVista Cardiac Package
Cardiology AI
The HeartVista Cardiac Package, featuring RTHawk, is an FDA-cleared AI-driven software that simplifies and accelerates cardiac MRI acquisition, offering one-click automation, real-time imaging, and advanced analysis for improved patient access and diagnostic efficiency.

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About HeartVista Cardiac Package

HeartVista, now operating as Vista.ai, is a healthcare AI company specializing in advanced MRI solutions. Their flagship product, the “One Click Cardiac Package” (now part of Vista AI Scan), received FDA clearance and is designed to significantly streamline and enhance cardiac MRI (CMR) examinations. For physicians, this AI-assisted software automates the prescription of standard cardiac views with a single click, enabling image acquisition in as little as 10 seconds while allowing the patient to breathe freely. The system incorporates a sophisticated neural network for artifact detection, alerting operators when image quality falls below acceptable thresholds and prompting reacquisition if necessary. It also optimizes inversion time with AI assistance for myocardial delayed-enhancement acquisition and provides preliminary measurements of left ventricular function, including ejection fraction, volumes, and mass.

The company’s core mission is to democratize MRI technology by making complex scans more accessible, faster, and more consistent, thereby addressing the challenges of limited access to highly trained technicians and the inherent complexity and time consumption of traditional MRI procedures. Initially focused on cardiac imaging, Vista.ai has expanded its scope to include AI-guided solutions for other anatomies, such as prostate, brain, and musculoskeletal scans, further broadening the impact of their automated MRI acquisition software. They also offer remote scanning services to facilitate MRI exams in facilities lacking specialized staff or expertise.

Focus Areas

AI-assisted MRI solutions cardiac MRI brain imaging prostate imaging spine imaging musculoskeletal imaging medical imaging automation real-time MRI

Business Intelligence

Key InvestorsKhosla Ventures, National Institute of Health (NIH) Small Business Innovation Research program, Jeff Rothschild, Leslie Ventures, Open Field Capital, Cedars Sinai Health Ventures, Intermountain Healthcare, Tampa General Hospital, Temple University, University of Utah Health
PartnershipsSiemens Healthineers, GE Healthcare, Stanford Health Care
TechnologyAI-driven, one-click MRI acquisition software; automates exam workflow; real-time MRI; artifact detection neural networks; direct control of MRI magnet; cloud-native (implied by software-only solution and remote capabilities)
FDA Clearancesmultiple (at least 5 by April 2020) cleared products (estimated)

What Physicians Need to Know

Specialization: Cardiac MRI Automation
HeartVista's core offering, the 'One Click Cardiac Package' (now Vista Cardiac), revolutionizes Cardiac MRI (CMR) by automating complex scan planning and acquisition. It enables standard cardiac views to be prescribed with a single click in as little as 10 seconds, significantly reducing exam times from traditional 90 minutes to under 15 minutes for cardiac ischemia exams, and full functional exams to 12 minutes.
Key Differentiator: AI-Driven Real-time Control
Unlike many AI solutions that analyze images post-acquisition, HeartVista's software takes direct control of the MRI magnet. It manipulates electromagnetic fields, constructs images, and runs pulse sequences, allowing for real-time automation of the scanning process. This includes AI-assisted artifact detection that prompts reacquisition if image quality is below an acceptable threshold, and optimization of inversion time.
Key Differentiator: Enhanced Patient Experience
The technology incorporates free-breathing and accelerated pulse sequences, eliminating the need for prolonged breath-holds. This significantly improves patient comfort, especially for those with arrhythmias, intolerance to long exams, or other health constraints, thereby increasing access to high-quality cardiac imaging.
Technology Stack: Advanced AI & Proprietary Apps
The system leverages advanced Artificial Intelligence and Machine Learning, including neural networks for artifact detection. It utilizes proprietary 'RTHawk Apps' for sophisticated acquisition and reconstruction methods, such as non-Cartesian, volumetric parallel imaging for 4D flow measurements, and offers on-the-fly adjustment of image acquisition parameters.
Expansion: Multi-Organ Imaging
While initially focused on cardiac MRI, HeartVista (now Vista AI) is actively expanding its AI-driven MRI solutions to other anatomical areas, including brain imaging, prostate imaging, and other specialties, aiming to deliver a full suite of AI-driven MRI capabilities.
Physician Tip

For physicians, HeartVista's Cardiac Package (Vista Cardiac) offers a significant leap in cardiac MRI accessibility and efficiency. The 'One Click' automation and AI-driven real-time control mean more consistent, high-quality scans, even with less experienced technologists, thereby democratizing access to gold-standard CMR. The reduced scan times (e.g., 12 minutes for a full functional exam) allow for increased patient throughput and shorter wait times (e.g., 1-day access from a 28-day backlog), which is crucial for timely diagnosis and treatment. Furthermore, the in-line analysis providing preliminary measures of left ventricular function and artifact detection ensures reliable data for confident reads. The ability to remotely monitor and guide exams also provides flexibility and support for clinical teams. This technology can elevate the standard of care for cardiac imaging, enhance patient experience, and improve patient outcomes by making advanced diagnostics more widely available and efficient.

HeartVista's software is designed as an accessory to existing MRI systems. It seamlessly connects to GE MRI systems, appearing as an additional pulse sequence within the GE protocol, and saves all DICOM images in the GE database. The company has also secured FDA 510(k) clearance and a joint commercial agreement with Siemens Healthineers, allowing its AI-guided acquisition software to integrate with Siemens MRI scanners using the Access-i interface, enabling the combination of HeartVista's and Siemens' native sequences. The software is installed on a hospital-provided workstation within the facility's network and communicates exclusively with the MRI, aiming for deployment on major MRI vendor platforms.

Products by HeartVista Cardiac Package

1 product in the directory

RTHawk
HeartVista Cardiac Package
Cardiology AI
The HeartVista Cardiac Package, featuring RTHawk, is an FDA-cleared AI-driven software that simplifies and accelerates cardiac MRI acquisition, offering one-click automation, real-time imaging, and advanced analysis for improved patient access and diagnostic efficiency.

What the Web Says

HeartVista's Cardiac Package is an AI-assisted MRI acquisition software designed to simplify and democratize cardiac MRI. It aims to address the challenges of cardiac MRI, such as complexity, long scan times, and the need for highly trained technicians, by automating many steps and reducing the number of clicks required for a scan. The software has received FDA clearance and is intended to make high-quality cardiac imaging more accessible and consistent across different sites and technologists.

Overall: Positive

Strengths

  • AI-assisted software automates cardiac MRI, reducing complexity and scan time.
  • Prescribes standard cardiac views with one click.
  • Incorporates artifact detection to identify and prompt reacquisition of low-quality images.
  • Optimizes inversion time for myocardial delayed-enhancement acquisition.
  • Provides preliminary measures of left ventricular function (ejection fraction, volumes, mass).
  • Enhances consistency and productivity of cardiac MRI studies across all levels of expertise.

Limitations

No significant limitations found in public reviews. Consider checking vendor documentation or requesting a demo for a thorough evaluation.

Based on reviews from: MD+DI (Medical Device + Diagnostics Industry), HeartVista Press Release, National Institute of Biomedical Imaging and Bioengineering (NIBIB), Vista AI (HeartVista's website)

Last updated: 2026-07-21

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Press & Coverage

OEM News
HeartVista Receives FDA 510(k) Clearance for Cardiac MRI Package
HeartVista received FDA 510(k) clearance for its AI-assisted Cardiac Package, which simplifies cardiac MRI acquisition with one-click view prescription and artifact detection. This aims to make cardiac MRI more accessible, time-efficient, and consistent.
2019-10
Ezra Scan
A First: FDA Clears an AI-Assisted Cardiac MRI Scanner
The FDA has cleared HeartVista's AI-assisted Cardiac Package, a 'one-click heart MRI examination tool' that uses AI to prescribe cardiac views, detect image quality issues, and provide preliminary measurements of left ventricular function.
2019-11
Cloudfront.net
AI Will Increase MRI's Accessibility, Accuracy, and Affordability for Cardiac Diagnostic Imaging
HeartVista's FDA-cleared Cardiac Package, known as 'One Click,' automates cardiac MRI exams, making them simpler, faster, and more consistent. The company, funded by NIH and Khosla Ventures, aims to elevate the standard of care for cardiac imaging.
2020-02
accessdata.fda.gov
HeartVista, Inc October 5, 2021. Mr. James J. Rogers Regulatory & Clinical Affairs and Strategic Quality Assurance 2625 - accessdata.fda.gov
This FDA document details changes and updates to the HeartVista Cardiac Package, including additional compatibility with Siemens Healthineers MRI scanners, new views and volumes, and improved features for T1/T2 map registration and artifact detection.
2021-10
Journal of Cardiovascular Magnetic Resonance (PMC - NIH)
Initial in vivo validation of real-time phase-contrast sequence
A study validated a real-time phase-contrast sequence using the HeartVista Cardiac Package, demonstrating good correlation with standard methods for cardiac output measurements and significantly reducing acquisition times.
2015-02
Journal of Cardiovascular Magnetic Resonance (PMC - NIH)
Comparison of a novel free breathing SSFP sequence with standard breath held SSFP- a pilot study
This pilot study compared HeartVista's novel free-breathing SSFP sequence from its Cardiac Package with standard breath-held SSFP, finding very good agreement in assessing left ventricular function and suggesting its potential for patients unable to breath-hold.
2015-02
accessdata.fda.gov
HeartVista, Inc. u018f 0U -DPHV 5RJHUV FDA Regulatory Affairs, Quality Assurance, and Clinical Studies 4984 El Camino Real, Suite
An FDA document from 2016 outlines the HeartVista Cardiac Package as a collection of RTHawk Apps designed to acquire, reconstruct, and display cardiovascular MR images, emphasizing its unchanged functions and features from the predicate device.
2016-06
accessdata.fda.gov
August 21, 2025 Vista AI, Inc. James Rogers Regulatory Affairs and Strategic Quality Assurance 431 Florence Street Suite 100 Pal - accessdata.fda.gov
This FDA submission from Vista AI, Inc. (formerly HeartVista) details updates to the HeartVista Cardiac Package, including automatic detection of motion artifacts, ungateable cardiac waveforms, and new AI-based image denoising.
2025-08
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