Viz RV/LV

by Viz.ai  · Based in United States → — AI-powered disease detection and intelligent care coordination
Emergency Medicine Pulmonology Radiology

Not publicly available
Regulatory Status Disclosed

Overview

Viz RV/LV is a software-only device developed by Viz.ai, designed to automatically measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA (Computed Tomography Pulmonary Angiogram) acquisition and report their ratio. This artificial intelligence (AI) algorithm accurately identifies the location and measurements of the ventricles and provides users with annotated images to visualize these measurements.

As a seamless component of the broader Viz PE Solution, Viz RV/LV aids in the detection of suspected central and segmental pulmonary emboli. Its integration enables an automated assessment of potential right ventricle dilation, a critical patient risk indicator for pulmonary embolism severity. The overarching Viz.ai One platform leverages over 50 FDA-cleared AI algorithms to accelerate diagnosis, streamline clinical workflows, and facilitate faster treatment decisions across various acute care settings, including seamless integration with EHR and PACS solutions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated Right Ventricle (RV) to Left Ventricle (LV) ratio measurement
  • Analysis of volumetric CTPA acquisitions
  • AI algorithm for identification and measurement of heart ventricles
  • Provides annotated images showing ventricular measurements
  • Seamless component of the Viz PE Solution for suspected pulmonary embolism detection
  • AI-powered alerts and notifications to care teams
  • High-fidelity mobile DICOM image viewer
  • HIPAA-compliant communication platform for care coordination
  • Integration with EHR and PACS solutions
  • Over 50 FDA-cleared AI algorithms on the Viz.ai One platform

Use Cases

  • Early detection and risk stratification of pulmonary embolism (PE)
  • Expediting treatment decisions for PE patients by assessing right heart strain
  • Facilitating rapid multidisciplinary communication and care coordination for PE
  • Automated assessment of potential right ventricle dilation in PE cases
  • Improving diagnostic acumen and expediting care for acute pulmonary embolism
  • Streamlining clinical workflows and reducing delays in acute care settings

What Physicians Need to Know

Cardiac CT/MRI Analysis
Viz RV/LV specifically analyzes volumetric CT Pulmonary Angiography (CTPA) acquisitions to measure the maximal diameters of the right and left ventricles of the heart and report their ratio. It uses an AI algorithm to identify ventricle locations and measurements, providing annotated images in DICOM format to assist in assessing right ventricle enlargement.
Heart Failure Risk Prediction (via Right Heart Strain)
The automated RV/LV ratio algorithm is a key indicator of pulmonary embolism (PE) severity and right heart strain, enabling care teams to respond more quickly to this critical patient risk. This assessment is vital for early detection and risk stratification in PE patients.
Real-Time Alert Capability
As part of the Viz PE Solution, Viz RV/LV utilizes AI-powered alerts to identify suspected PE and associated right heart strain, delivering this information quickly to the entire care team via push notifications.
ECG/EKG Analysis Capability (via Cardio Suite)
The broader Viz Cardio Suite, which includes Viz RV/LV, offers a Mobile ECG Viewer allowing care teams to quickly access, view, compare, and share 12-lead ECGs through a HIPAA-compliant app.
Echocardiography AI Features (via Cardio Suite)
The Viz Cardio Suite provides complete AI-structured echo reports in under 2 minutes, facilitated through a partnership with Us2.ai.
AHA/ACC Guideline Alignment
The Viz Cardio Suite, including the RV/LV algorithm, was launched during the American Heart Association (AHA) Scientific Sessions, indicating alignment with leading cardiology organizations. Its utility in expediting care for PE patients with right heart strain aligns with guideline-driven management.
Physician Tip

Viz RV/LV provides rapid, automated assessment of the RV/LV ratio from CTPA scans, which is crucial for quickly identifying right heart strain in patients with suspected pulmonary embolism (PE) and facilitating timely risk stratification. While the AI offers expedited insights and alerts, clinicians should always review non-compressed images on a diagnostic viewer and integrate these findings with comprehensive patient evaluation and clinical judgment, as the results are not intended for stand-alone clinical decision-making. Leverage the integrated communication tools to streamline multidisciplinary team collaboration for efficient treatment planning.

Viz RV/LV operates as part of the Viz.ai platform, analyzing CTPA scans forwarded to Viz.ai's Backend Server. The analysis results, including annotated images and summary reports, are exported in DICOM format and sent to a PACS destination for review. The broader Viz Cardio Suite supports patient data acquisition through CVIS and EHR integration, and the Viz.ai platform integrates directly into existing PACS, enhancing workflow and care coordination across departments. Communication among care teams is facilitated via a HIPAA-compliant platform.

Details

Category Cardiology AI, Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Not publicly available — N/A
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Viz RV/LV Software device received U.S. Food and Drug Administration (FDA) 510(k) clearance (K221100) on August 29, 2022. It is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. The results are not intended to be used on a stand-alone basis for clinical decision-making.

Integrations
EHR Not specified
Specialties Emergency Medicine, Pulmonology, Radiology

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Press & Coverage

Viz.ai
New Clinical Data Supports Viz.ai Solution for Improved Pulmonary Embolism Detection and Care Coordination
Viz.ai announced new clinical data supporting advancements in pulmonary embolism (PE) detection, with two studies demonstrating the real-world efficacy of Viz.ai's PE Module and Viz RV/LV algorithms. The studies showed improved PE detection, accelerated care coordination, and better healthcare workflow efficiency.
2023-09
Viz.ai
Indications for use | Viz.ai
This page details the indications for use of Viz RV/LV Software, which is designed to measure the maximal diameters of the right and left ventricles from a volumetric CTPA acquisition and report their ratio using an AI algorithm. The results are not intended for stand-alone clinical decision-making.
unknown
accessdata.fda.gov
Viz.ai, Inc. Vi Ma Regulatory Affair Specialist 201 Mission Street, 12th Floor SAN FRANCISCO CA 94105 Re: K221100 Trade/De - accessdata.fda.gov
This FDA document details the 510(k) clearance for Viz RV/LV (K221100), outlining its intended use to measure right and left ventricular diameters from CTPA acquisitions using AI. It emphasizes that the software's results are not for stand-alone clinical decision-making.
2022-08
510k Monitor
Watch Viz. Ai, Inc. - FDA 510(k) clearances & recalls - 510k Monitor
This monitoring site lists FDA 510(k) clearances for Viz.ai, Inc. products, including Viz RV/LV (K221100) which received clearance on August 29, 2022. It provides a comprehensive overview of their cleared medical devices.
2022-08
Viz.ai
Vizu2122 PE | AI-Powered Vascular Care Coordination
Viz PE, an AI-powered solution for suspected pulmonary embolism, utilizes Viz RV/LV to identify right heart strain. Clinical studies indicate that this solution leads to shorter time-to-assessment and anticoagulation, with a significant reduction in in-hospital PE mortality risk.
unknown
Orthogonal
SaMD Cleared by the FDA: The Ultimate Running List - Orthogonal
This article provides a comprehensive list of Software as a Medical Device (SaMD) cleared by the FDA, including Viz RV/LV, which was cleared on August 29, 2022, for radiology applications. The list draws on publicly available FDA data.
2024-10
PMC (PubMed Central)
Artificial intelligence in modern clinical practice (Review) - PMC
A review article discusses the role of AI in modern clinical practice, highlighting Viz.ai's triage platform for pulmonary embolism risk stratification, with AI tools supporting automated CT-derived RV/LV ratio assessments. Viz RV/LV (K221100) is noted as an FDA-approved device.
2025-01
unknown
Artificial intelligence in cardiac amyloidosis: Expert insights on adoption challenges, opportunities and best practices for developing
This expert insight discusses the adoption of AI in cardiac amyloidosis, mentioning Viz RV/LV (K221100) as an FDA-authorized AI tool relevant to cardiovascular applications, specifically for RV/LV Ratio in Pulmonary Embolism from Cardiac CT.
2025-05

Videos

Product demos, reviews, and walkthroughs for Viz RV/LV.

View all on YouTube

Frequently Asked Questions

The Viz RV/LV algorithm is a seamless component of the Viz PE Solution, designed to integrate directly into existing radiology and care team workflows. It automatically measures RV/LV diameters from CTPA images, flagging suspected PE and potential right ventricle dilation within minutes, and then sends push notifications to specified users for expedited review and care coordination.
Yes, Viz RV/LV has received FDA 510(k) clearance for its automated RV/LV ratio algorithm. Viz.ai is committed to data protection, complying with regulations like HIPAA, GDPR, and CCPA, and utilizes cloud-native industry standards, SOC 2 Type II, and ISO certifications to ensure system and data security.
Traditional methods for assessing PE severity involve manual measurement of RV/LV ratios by radiologists and cardiologists, along with clinical judgment based on patient presentation and other diagnostic findings. While other AI solutions exist for medical imaging analysis, Viz.ai is noted for its comprehensive care coordination platform across multiple conditions.
Viz.ai generally operates on a subscription-based model, with pricing varying significantly based on the size of the hospital or health system and the number of modules or diseases targeted. While specific RV/LV pricing isn't publicly disclosed, overall Viz.ai costs can range from tens of thousands to over a million dollars annually.
While studies show a significant positive correlation between algorithmic and manual RV/LV ratio calculations, AI algorithms can produce false positives or negatives, and their quality depends on the datasets they were trained on, raising concerns about potential bias if data isn't representative. Physicians retain the ultimate responsibility for clinical decision-making, using the AI as an assistive tool to augment their capacity and expedite care, not replace their judgment.
Viz RV/LV expedites critical decision-making by providing automated assessment of potential right ventricle dilation, a key indicator of PE severity, quickly to the entire care team. This facilitates faster triage, appropriate treatment, and improved care coordination, ultimately aiming to reduce delays and enhance patient outcomes.
Viz.ai solutions are designed to integrate seamlessly into a healthcare organization's existing IT framework and workflows, connecting to any imaging device using the DICOM standard. The platform is cloud-native, scalable, and aims to enhance existing workflows without significant disruptions or compatibility issues.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19

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