AISAP Cardio

by AISAP  · Based in Israel → — Transforming Point-of-Care Ultrasound with expert-level AI
Cardiology Emergency Medicine Radiology

Regulatory Status Disclosed

Overview

AISAP Cardio is an innovative, AI-powered point-of-care ultrasound (POCUS) software platform designed to enhance cardiac diagnostics for both novice and experienced physicians. It provides objective, clinically relevant cardiac and valvular measurements beyond traditional POCUS, increasing confidence and expanding the role of cardiac ultrasound in everyday clinical practice.

The cloud-based platform integrates computer-assisted diagnosis (CADx) modules for valvular pathologies and eight key cardiac measurements into a single, comprehensive software package. It automatically generates analyses, interpretations, and reports in minutes, empowering clinicians with basic scanning skills to accurately diagnose up to 90% of the most common cardiac structural and functional parameters right at the bedside.

AISAP Cardio is a vendor-agnostic, scalable solution that seamlessly integrates into existing clinical workflows, Electronic Health Record (EHR)/Electronic Medical Record (EMR), and Picture Archiving and Communication Systems (PACS) technologies. It is intended to generate reliable and validated assessments early in the patient evaluation process and throughout the course of therapy. The platform also offers telemedicine, cloud computing, and education tools.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered interpretation for early cardiac disease detection
  • Comprehensive cardiac ultrasound software package
  • Automated generation of analyses, interpretations, and reports
  • Assessment of valvular pathologies (mitral, tricuspid, aortic regurgitation, aortic stenosis)
  • Measurement of Left Ventricle Ejection Fraction (LVEF)
  • Measurement of right and left ventricular dimensions, atrial areas, ascending aorta diameter, and IVC diameter
  • Vendor-agnostic and scalable solution
  • Integration with existing clinical workflows, EHR/EMR, and PACS
  • Cloud-based platform with telemedicine capabilities
  • Education tools for clinicians

Use Cases

  • Early detection of structural heart disease and heart failure
  • Shorten diagnostic turnaround time
  • Reduce length of hospital stay
  • Avoid unnecessary patient transfers
  • Enhancing cardiac POCUS for novice and experienced physicians
  • POCUS OS: AI operating system for any POCUS device

What Physicians Need to Know

Echocardiography AI Features
AISAP Cardio is an FDA-cleared AI-powered point-of-care ultrasound (POCUS) platform that provides real-time, AI-assisted cardiac ultrasound diagnostics at the bedside. It analyzes 12 key cardiac measurements and findings, from ejection fraction to valvular pathology, to support earlier diagnosis and improve clinical efficiency. The platform integrates four computer-assisted diagnosis modules for valvular pathologies and eight essential cardiac measurements, allowing clinicians to accurately diagnose up to 90% of common cardiac structural and functional parameters at the bedside within minutes. It provides accurate evaluations of cardiac conditions, including valvular pathology (mitral, tricuspid, aortic regurgitations, and aortic stenosis), left ventricle ejection fraction (LVEF), and ventricular dimensions. AISAP Cardio can detect significant valvular disease and ventricular dysfunction using a single, focused ultrasound view, even when images are acquired by non-cardiologists using handheld devices. The AI has achieved an Area Under the Curve (AUC) of up to 0.97 for detecting reduced ejection fraction and 0.95 for right ventricular dysfunction. Studies show that AISAP Cardio improves clinician accuracy in interpreting point-of-care echocardiograms.
Heart Failure Risk Prediction
AISAP Cardio is a comprehensive AI solution for diagnosing heart failure. It can identify severe heart failure with a low ejection fraction within minutes, enabling swift referral and treatment. The platform helps in the early detection of heart failure, even in asymptomatic patients, by performing screening echoes in primary care settings. AISAP Cardio's deep learning model can accurately detect ventricular dysfunction and reduced ejection fraction.
Coronary Artery Assessment
While AISAP Cardio primarily focuses on structural heart disease and heart failure diagnostics via echocardiography, it has been instrumental in cases where real-time insights expedited catheterization, uncovering severe three-vessel coronary disease.
Cardiac Monitoring Integration
AISAP Cardio integrates with ultrasound devices across manufacturers. It is a vendor-agnostic solution that integrates smoothly with existing EHR/EMR and PACS systems.
AHA/ACC Guideline Alignment
The AISAP CARDIO V1.0 algorithms were trained at academic institutions that perform cardiac ultrasound examinations and interpretations according to American Society of Echocardiography (ASE) guidelines. The ground truth for performance assessment was established by cardiologists following ASE guidelines. AISAP CARDIO V1.0 is adjunctive to cardiac POCUS use by privileged physicians in use scenarios supported by clinical guidelines. When significant valve pathology is suspected, comprehensive echocardiography should be considered in accordance with relevant professional guidelines.
Real-Time Alert Capability
AISAP Cardio provides real-time, AI-assisted cardiac ultrasound diagnostics at the bedside. It delivers expert-level results instantly at the point of care, shortening turnaround time. The platform provides immediate clarity and enables rapid, targeted treatment. It also provides real-time support for clinical decision-making.
Physician Tip

AISAP Cardio empowers a wide range of clinicians, including non-cardiologists, to perform and interpret cardiac POCUS at the bedside, facilitating earlier detection and management of structural heart disease and heart failure. It can significantly reduce echocardiogram reporting time by up to 90%, streamlining clinical workflows and allowing more focus on patient interaction. The platform's ability to provide quantitative ejection fraction and other cardiac measurements offers objective data for tracking patient progress over time, which is particularly useful for novice users and for consistent follow-up. Utilizing AISAP Cardio can lead to faster clinical decisions, improved patient outcomes, and can help avoid unnecessary patient transfers by enabling comprehensive cardiac assessments at the point of care.

AISAP Cardio is designed for seamless integration into existing healthcare IT infrastructure. It is a vendor-agnostic solution that integrates with ultrasound devices from various manufacturers. The platform connects automatically into any electronic health record (EHR) system and integrates smoothly with PACS and EMR systems, allowing AI-generated measurements and structured findings to flow directly into clinical reports.

Details

Category Cardiology AI
Pricing Unknown
DeploymentCloud-based
Mobile AppYes
Data Export Yes
Training Yes
Compliance
BAA AvailableUnknown
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Emergency Medicine, Radiology

Support & Reliability

Training Provided Yes

What the Web Says

AISAP Cardio is an AI-powered point-of-care ultrasound (POCUS) software platform that assists physicians in interpreting cardiac ultrasounds and diagnosing heart conditions. It has received FDA 510(k) clearance and is designed to integrate into existing clinical workflows and EMR/PACS systems. The platform aims to improve the accuracy of non-cardiologist physicians in interpreting echocardiograms, leading to earlier detection and treatment of structural heart diseases and heart failure. Studies have shown high sensitivity and specificity for detecting major valve diseases and ventricular dysfunction.

Overall: Positive

Strengths

  • Improves accuracy of non-cardiologist physicians in interpreting echocardiograms.
  • Enables rapid, expert-level cardiac reads at the bedside, reducing wait times for comprehensive echoes.
  • Provides quantitative measurements and valvular assessments not typically available in standard POCUS exams.
  • Seamlessly integrates with existing EHR/EMR and PACS systems.
  • Aids in early detection of structural heart disease and heart failure, potentially leading to better patient outcomes and cost savings.
  • Validated through extensive clinical trials with high sensitivity and specificity for detecting major valve diseases.

Limitations

  • Requires physicians to be trained and privileged by their organization for cardiac POCUS use.
  • Not validated for congenital heart disease, intra-cardiac lesions, prosthetic valves, or in the presence of ventricular assist devices.
  • Indicated for use in adult patients only.
  • AI-supported assessment of right-sided function still needs improvement.
  • Patient management decisions should not be made solely on the results of the software analysis.
  • Potential for bias in AI algorithms if training data is uniform or healthcare procedures are unfair.

Based on reviews from: dicardiology.com, aisap.ai, fda.gov, youtube.com, pocus.org, timesofisrael.com, hospitals-management.com, prnewswire.com, cardiovascularbusiness.com, mdspire.com, businesswire.com

Last updated: 2026-10-28

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Press & Coverage

medaxiom.com
MedAxiom and AISAP Partner to Advance AI-Driven Cardiac Diagnosis at the Point of Care
MedAxiom announced an industry partnership with AISAP to bring AI-powered cardiac diagnostics to the point of care. AISAP Cardio, an FDA-cleared AI solution, aims to provide comprehensive cardiac assessment reports from bedside ultrasound scans, improving diagnostic efficiency and patient care management.
2026-10
prnewswire.com
New Peer-Reviewed Study Validates AISAP's AI Ability to Detect Major Heart Disease from a Single Ultrasound View
AISAP announced the publication of a new clinical study in Frontiers in Digital Health, providing evidence that its deep learning model can accurately detect significant valvular disease and ventricular dysfunction from a single, focused ultrasound view. This study highlights the potential for AISAP's POCAD™ platform to enable timely, bedside decision-making and immediate detection of heart disease.
2026-01
prnewswire.com
AISAP Named a Featured Case Study in New WHO Report on AI in Healthcare
AISAP was featured as a case study in the World Health Organization's report "Bridging Theory and Practice," highlighting its work with Sheba Medical Center in applying AI in health systems. The case study cited results from a prospective clinical study where AI-guided POCUS led to treatment changes, early discharge, or care transitions.
2026-07
pocus.org
Revolutionizing Cardiology with AISAP CARDIO: The Power of AI in POCUS
This article discusses how AISAP Cardio, an AI-powered point-of-care ultrasound software, is revolutionizing cardiology by enabling non-cardiologists to accurately interpret echocardiograms. The platform received FDA 510(k) clearance in August 2024 and has demonstrated 93% sensitivity and specificity for significant major valve diseases.
2025-01
businesswire.com
AISAP's CARDIO AI-powered Point-of-Care Ultrasound Diagnostic Assessment Software Receives FDA Clearance
AISAP announced that its AI-powered AISAP Cardio point-of-care ultrasound (POCUS) software platform received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The cloud-based platform combines four computer-assisted diagnosis modules for valvular pathologies and eight key measurements into a single, comprehensive cardiac ultrasound software package.
2024-08
healio.com
FDA clears AI-powered POCUS platform for structural heart disease, heart failure
The FDA granted 510(k) clearance to AISAP for its AI-powered point-of-care ultrasound software platform, AISAP Cardio, for the diagnosis of multiple cardiac pathologies. The platform demonstrated 93% sensitivity and specificity in diagnosing aortic stenosis and regurgitation, and mitral and tricuspid regurgitation.
2024-08
fda.gov
AISAP CARDIO V1.0 510(k) Premarket Notification
The FDA granted 510(k) clearance for AISAP Cardio V1.0 on August 1, 2024. This machine learning-based decision support software is indicated as an adjunct to diagnostic Cardiac point of care ultrasound (C-POCUS) for adult patients undergoing assessment for cardiac disease.
2024-08
frontiersin.org
Artificial intelligence assessment of valvular disease and ventricular function by a single echocardiography view
This study assessed the interpretation of key cardiac measurements on POCUS images by an AI-enabled device (AISAP Cardio V1.0). The device was trained using labeled echocardiography data and evaluated for seven measurements, demonstrating its ability to assist in cardiac assessment.
2026-01

Videos

Product demos, reviews, and walkthroughs for AISAP Cardio.

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Frequently Asked Questions

AISAP Cardio integrates into existing workflows by providing AI-guided image acquisition and automated cardiac analysis, allowing clinicians to perform bedside cardiac assessments without extensive specialist training. It's primarily used to diagnose heart failure and structural heart disease, offering rapid, expert-level results for valvular pathologies and key cardiac measurements, which can be particularly beneficial in emergency medicine, critical care, and primary care settings.
AISAP Cardio is an FDA-cleared AI-powered point-of-care ultrasound (POCUS) software platform. It received 510(k) clearance in August 2024 for four diagnostic modules and eight automated measurements. Physicians using AISAP Cardio should be trained and privileged by their organization and perform cardiac POCUS according to their specialty professional society clinical guidelines. Patient management decisions should not be made solely on the software's analysis, and comprehensive echocardiography should be considered for suspected significant valve pathology.
AISAP Cardio is indicated for use in adult patients only. It has not been validated for the assessment of congenital heart disease, intra-cardiac lesions (e.g., tumors, thrombi, vegetations), prosthetic valves, or in the presence of ventricular assist devices. Additionally, while AI-enhanced FoCUS shows high sensitivity for detecting reduced left ventricular function and valvular disease, its sensitivity for right-sided abnormalities is lower.
AISAP Cardio aims to bridge the gap in cardiac assessment by enabling non-cardiologists to interpret echocardiograms with accuracy comparable to expert cardiologists, especially in settings where specialized expertise is limited. It provides automated analyses and reports for valvular pathologies and key cardiac measurements, which can be done at the bedside within minutes, unlike traditional echocardiography which often requires specialized technicians and can take longer. While it doesn't replace a full echocardiogram, it provides core information for rapid assessment.
The pricing model for AISAP Cardio is not explicitly detailed in the provided information. However, it is highlighted that the platform can lead to cost savings and improved efficiencies for health systems by enabling earlier detection and treatment, reducing length of stay, and avoiding unnecessary patient transfers. The use of AISAP Cardio has shown a 2.5x return on investment for every dollar spent through increased procedure revenue and significant cost savings at Sheba Medical Center.

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Suggest an Edit → | Report an issue | Last Verified: 2026-10-14 | First Added: 2026-04-17
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