FDA 510(k) Select Modalities CE MDR NMPA CPT 75580 Active AVIA Health Marketplace

CT-FFR. AI Plaque Analysis. Automated Echo.
One platform, one integration, one contract.

CardiaX orchestrates AI-powered cardiac diagnosis across 6 modalities — from a single hospital integration.

86.9% Sensitivity
6 Modalities
5 Vendor Partners
$1,000+ Medicare Reimbursement
Epic
·
Cerner
·
GE PACS
·
Philips IntelliSpace
·
Siemens syngo.via
·
Any DICOM-compliant system
Platform Capabilities

Six modalities. One integration.

Every cardiac AI tool your cardiologists need — configured to your workflow, integrated with your PACS.

ECG Triage (HEARTio)

⚠ INVESTIGATIONAL — NOT FDA-CLEARED

CT-FFR Analysis (Keya DeepVessel)

✓ FDA 510(k) Cleared

Coronary Plaque & Inflammation (Caristo)

✓ FDA 510(k) · CE MDR

Cardiac MRI (CASIS QIR-MR)

✓ FDA 510(k) Cleared

4D Flow Hemodynamics (CASIS QIR-4D)

✓ FDA 510(k) Cleared

AI Echocardiography (Ligence)

✓ FDA 510(k) ×2 · CE MDR Class IIa

Modality 01

ECG Triage (HEARTio)

⚠ INVESTIGATIONAL — NOT FOR SALE IN THE US

AI-powered ECG interpretation for rapid triage of cardiac emergencies. Screens 16,000+ patient dataset with 93.1% sensitivity. INVESTIGATIONAL USE ONLY — not approved for clinical use in the United States.

Sensitivity
93.1%
Dataset
16,000+ pts
Status
Investigational
Vendor
HEARTio

Modality 02

CT-FFR Analysis (Keya DeepVessel)

✓ FDA 510(k) Cleared

Non-invasive fractional flow reserve from CT angiography. Reduces unnecessary cath lab referrals and bills under CPT 75580 — the first AI cardiac imaging code with active Medicare reimbursement.

Sensitivity
86.9%
Specificity
86.7%
CPT Code
75580
Reimbursement
$1,000+ Medicare

Modality 03

Coronary Plaque & Inflammation (Caristo)

✓ FDA 510(k) (CaRi-Plaque™) · CE MDR (CaRi-Heart®)

Quantifies coronary plaque burden and pericoronary inflammation from CT. CaRi-Plaque™ is FDA 510(k) cleared. CaRi-Heart® is CE-marked; US FDA clearance anticipated 2026.

CaRi-Plaque™
FDA 510(k)
CaRi-Heart®
CE MDR
Vendor
Caristo
Modality
CCTA

Modality 04

Cardiac MRI (CASIS QIR-MR)

✓ FDA 510(k) Cleared

Automated cardiac MRI analysis with AI-powered segmentation and quantification. Delivers fast, reproducible measurements of cardiac structure and function directly in your PACS workflow.

Clearance
FDA 510(k)
Modality
Cardiac MRI
Vendor
CASIS
Output
PACS-native

Modality 05

4D Flow Hemodynamics (CASIS QIR-4D)

✓ FDA 510(k) Cleared

Advanced hemodynamic analysis using 4D flow MRI. Visualizes blood flow patterns, wall shear stress, and pressure gradients — critical for structural heart disease planning.

Clearance
FDA 510(k)
Modality
4D Flow MRI
Vendor
CASIS
Use Case
Structural Heart

Modality 06

AI Echocardiography (Ligence)

✓ FDA 510(k) ×2 · CE MDR Class IIa

Automated echocardiography analysis with real-time AI measurements. Two FDA clearances and CE MDR Class IIa. Delivers automated EF, wall motion, and structural measurements at the point of care.

FDA Clearances
×2
CE MDR
Class IIa
Vendor
Ligence
Modality
Echocardiography
Clinical Workflows

Built for how hospitals actually work

CardiaX is configured to support the workflows your care team runs every day.

01

Chest Pain Triage

Rapidly stratify chest pain patients using CT-FFR and ECG AI — reducing unnecessary cath lab referrals and ED time.

02

Pre-Cath Lab Optimization

Use CT-FFR (CPT 75580) to identify which patients truly need invasive angiography. Fewer unnecessary procedures, better outcomes.

03

Heart Failure Screening

AI echo and cardiac MRI quantify EF and wall motion at scale — enabling earlier identification of at-risk patients in your panel.

04

Cardiac Surgery Planning

4D flow hemodynamic analysis and structural MRI provide the detail surgical teams need for complex valve and aortic cases.

05

Population Health Screening

Plaque burden and inflammation analysis (Caristo) enables proactive cardiovascular risk management across your patient population.

06

Revenue Optimization

CT-FFR analysis bills under CPT 75580 — the active Medicare code — generating $1,000+ per qualifying study. Revenue from day one.

Hospital IT

Zero infrastructure disruption

Designed for the IT director audience. CardiaX integrates with what you already have.

📡

DICOM-Native

CardiaX operates natively on DICOM data. No proprietary image conversion, no data migration — works with the imaging data your scanners already produce.

DICOM 3.0 No migration Any scanner
📂

PACS-Integrated

Results appear directly in your existing PACS viewer. No separate login, no separate dashboard — cardiologists see AI outputs where they already read images.

GE PACS Philips IntelliSpace Siemens syngo.via
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HL7/FHIR Compatible

Bidirectional EHR integration via HL7 v2 and FHIR R4. AI results flow into Epic and Cerner automatically — no manual data entry for your clinical staff.

HL7 v2 FHIR R4 Epic & Cerner
Clinical Evidence

Peer-reviewed data, not marketing copy

Every modality in the CardiaX platform has published clinical validation data.

CT-FFR — ADAPT Study

86.9%
Sensitivity
86.7%
Specificity
269 patients • 10 clinical sites • Keya DeepVessel (CT-FFR) • FDA 510(k) cleared • CPT 75580

CT-FFR — Patient-Level Accuracy

85.2%
Accuracy
90.1%
NPV
High negative predictive value — safely rules out hemodynamically significant CAD without invasive testing

ECG AI — HEARTio

⚠ INVESTIGATIONAL
93.1%
Sensitivity
16,000+
Patient dataset
INVESTIGATIONAL — NOT FOR SALE IN THE US. Not FDA-cleared. Data from pre-market clinical studies only.
86.9%
CT-FFR Sensitivity (ADAPT Study)
5
AI Vendor Partners
6
Cardiac AI Modalities
CPT 75580
Active Medicare Reimbursement Code
Get Started

See it configured for your hospital.

Tell us your infrastructure and we'll show you exactly how CardiaX would integrate — which modalities you can deploy, how results appear in your PACS, and what Medicare billing looks like for your case volume.

No infrastructure changes required
Works with your existing PACS and EHR
CPT 75580 revenue from day one
Response within 24 hours

Request received.

We'll reach out within 24 hours with a configuration assessment tailored to your hospital's infrastructure.

Questions? Email nathan.qin@cardiaxintelligence.com

Deployment

Up and running in weeks, not months

Three steps from conversation to live clinical deployment.

1

Tell us your infrastructure

Share your current PACS vendor, EHR system, scanner types, and which modalities matter most to your cardiologists. We map CardiaX to your exact setup.

2

One integration, every modality

A single CardiaX integration connects your PACS to all six AI engines. No separate vendor contracts. No multiple IT projects. One configuration — all modalities live.

3

Results in your workflow

AI outputs appear directly in your PACS viewer and flow back into Epic or Cerner. Cardiologists see results where they already work — zero workflow disruption.

Why CardiaX

Not a bundle. An operating system.

Point solutions fragment your workflow. CardiaX integrates it.

One contract, six modalities

Instead of negotiating with five separate AI vendors, CardiaX handles all vendor relationships. One contract, one integration, all modalities live simultaneously.

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Built for hospital IT

DICOM-native, PACS-integrated, HL7/FHIR compatible. IT directors get one integration project, not five. Existing infrastructure, no rip-and-replace.

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Revenue from day one

CT-FFR analysis bills under CPT 75580 — generating $1,000+ per study in active Medicare reimbursement. Deployment pays for itself before you finish onboarding.

Regulatory-grade AI only

Every modality is FDA 510(k) cleared or CE MDR marked (except ECGio, investigational). No research tools. No unvalidated algorithms. Clinically-cleared AI only.

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Configurable per cardiologist

Different cardiologists need different tools. CardiaX lets each physician configure their preferred AI outputs, thresholds, and workflow integration preferences.

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HIPAA-compliant by design

All data processing respects HIPAA requirements. PHI stays within your network boundary. Vendor agreements include standard BAA terms.

Your 25-bed hospital now has the same diagnostic capability as Cleveland Clinic.

Six FDA-cleared AI modalities. One integration. Active Medicare reimbursement from day one.