CardioVision
Overview
CardioVision by iCardio.ai is an FDA 510(k) cleared artificial intelligence (AI) software designed as a diagnostic aid for the detection of aortic stenosis (AS). It is intended for use by interpreting clinicians to support the determination of the likelihood of clinically significant aortic stenosis.
- What it does: CardioVision analyzes a single cine-loop DICOM of the parasternal long axis (PLAX) view from an echocardiogram. Using deep learning, it provides a binary classification of “none/mild” or “moderate/severe,” indicating whether the echocardiogram is consistent with moderate or severe aortic stenosis. The system can also identify when image quality is insufficient, resulting in an “indeterminate” output.
- Who it is for: This tool is for cardiologists and other interpreting clinicians in care settings where echocardiographic exams are performed, including outpatient and primary care environments. It is indicated for use in adult populations over 21 years of age.
- How it fits a clinical or practice workflow: CardioVision is a standalone image analysis software that integrates with existing medical imaging workflows, including PACS, DICOM viewers, and imaging worklists. It provides adjunctive information to assist clinicians in diagnosing AS, with the final diagnosis remaining the responsibility of the interpreting clinician, who should consider all patient data.
- Notable capabilities: CardioVision has received FDA 510(k) clearance and was granted FDA Breakthrough Device Designation for its capability to automatically detect aortic stenosis. It is designed to function effectively even with varying image quality, including in outpatient imaging environments.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered detection of moderate to severe Aortic Stenosis
- Input: DICOM-compliant echocardiogram (parasternal long-axis view)
- Output: Binary classification of 'none/mild' or 'moderate/severe' aortic stenosis
- Functions as an adjunctive diagnostic aid for interpreting clinicians
- Utilizes deep learning for prediction without explicit variable measurement
- Integrates into existing PACS workflows
- Viable for use with handheld ultrasound devices
Use Cases
- Early detection and screening for aortic stenosis
- Assisting clinicians in diagnosing aortic stenosis from echocardiograms
- Improving diagnostic accuracy and efficiency in cardiovascular diagnostics
- Supporting clinical decision-making in outpatient settings, such as primary care
- Reducing diagnostic variability in echocardiogram interpretation
What Physicians Need to Know
CardioVisionu2122 serves as a valuable diagnostic aid for detecting aortic stenosis, particularly in outpatient or primary care settings where early identification might be missed. Its ability to analyze a single PLAX view simplifies the screening process. However, patient management decisions should not be based solely on CardioVisionu2122 results, as it is intended for adjunctive use with other clinical information. The broader iCardio.ai platform, including tools like EchoMeasureu2122, can significantly reduce sonographer fatigue and diagnostic variability by automating numerous echocardiographic measurements, enhancing efficiency and accuracy in reporting.
iCardio.ai's solutions, including CardioVisionu2122, are built for integration with PACS and ultrasound hardware, facilitating a streamlined workflow. Partnerships with leading healthcare technology providers like GE Healthcare and Viz.ai expand its reach and interoperability. The availability of a simple API allows for custom-tailored automated solutions and deployment of existing algorithms within various clinical pipelines.
Details
| Category | Cardiology AI |
| Pricing | Tiered pricing with a base charge and per-scan fees. — Tiered base charge $6,000-15,000/month; $2-4/scan |
| Deployment | Integrates into existing PACS workflows; built for PACS and hardware. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated CardioVision (K251293) received FDA 510(k) clearance on November 21, 2025, as a Class II Adjunctive Heart Failure Status Indicator (product code QUO). It is intended as a diagnostic aid for detecting moderate or severe aortic stenosis from echocardiogram images. It also received FDA Breakthrough Device Designation for its Aortic Stenosis detection tool. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Radiology |
What the Web Says
CardioVision, developed by iCardio.ai, is an AI-powered software designed to automate and enhance the interpretation of echocardiograms, particularly for detecting aortic stenosis. It has received FDA 510(k) clearance and Breakthrough Device Designation for its aortic stenosis detection tool. The technology aims to improve diagnostic accuracy and efficiency, reducing manual workload for clinicians and potentially leading to earlier diagnoses and improved patient outcomes.
Overall: PositiveStrengths
- Automates echocardiography measurements and generates preliminary reports, saving time for clinicians.
- Delivers high accuracy (99%+) in echocardiogram analysis, reducing human error.
- Integrates seamlessly into existing medical imaging systems.
- Aids in the early and precise detection of aortic stenosis, a severe condition.
- Reduces manual clinician workload by up to 96%.
- Leverages a large proprietary dataset of over 200 million ultrasound images for robust AI training.
Limitations
- Limited independent reviews from physicians and healthcare IT professionals are publicly available, making it difficult to gauge widespread adoption and satisfaction.
- General concerns exist within the medical community regarding the ethical implications of AI in cardiology, such as balancing automation with clinician oversight and potential medico-legal liabilities.
- Some general AI medical diagnostic platforms on G2 have received negative feedback regarding customer service and review authenticity.
- The app version of CardioVision appears to be a separate patient-facing health management tool, not directly related to the AI diagnostic software, which could cause confusion.
- The reliability of reviews on platforms like Capterra can be questionable due to incentivized reviews.
Based on reviews from: iCardio.ai, Cardia Vision, G2, GenAI Labs, Product Hunt, Reddit, Viz.ai, MedAxiom, Tebra, YouTube, PMC, Google Play, Trustpilot, IndexBox, Cleveland Clinic, American Heart Association Journals, Quora
Last updated: 2026-07-18
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