Frequently Asked Questions

What Hospital Leaders Ask About AI Cardiac Diagnostics

Straight answers for clinical directors, CFOs, and IT teams evaluating FFR-CT deployment. No jargon, no sales pitch — just the facts.

Clinical & Regulatory

Yes. Keya Medical's DEEPVESSEL FFR is FDA 510(k) cleared for non-invasive fractional flow reserve analysis from coronary CT angiography data.

The CREDENCE trial — the largest prospective FFR-CT validation study — confirmed 86.9% per-vessel sensitivity and 86.7% specificity against invasive FFR as the reference standard.

Read the full clinical evidence breakdown →

No. FFR-CT reduces unnecessary diagnostic catheterizations by identifying patients who don't need invasive testing.

Here's the context: approximately 60% of diagnostic catheterizations find no significant coronary artery disease. That's an invasive procedure — with real complication risk and a $15,000+ cost — that didn't change the treatment plan.

FFR-CT acts as a gatekeeper. Patients with hemodynamically significant lesions still proceed to the cath lab. Patients without significant disease avoid an invasive procedure entirely.

Any 64+ slice CT scanner with coronary CTA capability. That's it.

CardiaX deploys as a software-only overlay on your existing equipment. No new hardware purchases. No facility construction. No scanner replacement. No downtime during installation.

See the full 30-day deployment process →

Financial & Reimbursement

$400–500 per case for FFR-CT analysis, depending on contract volume.

This includes cloud-based AI processing, structured report generation, PACS integration, and ongoing software updates. No additional per-seat licensing or maintenance fees.

CPT 75580 reimburses approximately $1,017 per case (Based on 2024 CMS Physician Fee Schedule. Rates subject to annual revision.) under Medicare. Commercial payer acceptance is at 89% across major plans.

At $400–500 cost per case, the net margin is $517–617 per case before overhead. That's a positive-margin clinical service from Day 1.

Read the full CPT 75580 billing guide →

Revenue from Day 1 post-go-live. There's no multi-year payback period because there's no capital equipment to amortize.

At 10 cases per week, projected annual revenue is $528K with a net margin of approximately $269K–321K after per-case costs.

Scale math: 5 cases/week = $264K revenue. 20 cases/week = $1.06M revenue. The economics work at any volume above 3 cases per week.

Yes. The $272M Rural Health Transformation fund covers diagnostic modernization for eligible rural facilities.

Because FFR-CT is a software-only deployment (no capital equipment), it qualifies under operational technology grants rather than facility construction categories — which simplifies the application process significantly.

Read the full Alaska funding guide →

Implementation & Integration

30 days from signed agreement to first billable case. Four structured phases:

Days 1–5: Infrastructure assessment — CT scanner compatibility, EHR review, DICOM pathway audit.
Days 5–15: Software integration — install on existing hardware, configure image routing, activate billing module.
Days 15–25: Staff training — radiologist workflow, technician protocols, billing & coding walkthrough.
Days 25–30: Go-live — first billable cases, parallel validation, ongoing optimization.

See the detailed deployment playbook →

No. Existing radiologists and CT technicians receive workflow training as part of the 30-day deployment. AI-assisted reads integrate directly into your current PACS workflow.

Radiologist training is 4–6 hours (CME-eligible). Technician training focuses on optimal CCTA acquisition protocols. No additional FTEs required.

Yes. CardiaX supports Epic, Cerner, Meditech, and all major EHR systems via standard DICOM and HL7 integration.

Structured FFR-CT reports are delivered directly into the radiologist's existing reading workflow. No separate portal, no extra login, no workflow disruption.

Operations & Reliability

All cases are reviewed by board-certified radiologists. The AI provides decision support — quantitative FFR values and vessel-specific analysis — not autonomous diagnosis.

The radiologist retains full clinical authority on every case. If image quality is insufficient for reliable analysis, the system flags the case for repeat acquisition or alternative workup rather than producing a low-confidence result.

Cloud-based processing with a 99.9% uptime SLA. Processing time is typically under 30 minutes per case.

An on-premise deployment option is available for high-volume centers or facilities with data residency requirements. Both options include 24/7 technical support and automatic software updates.

Still Have Questions?

Our clinical team will walk you through deployment specifics for your facility — scanner compatibility, billing setup, and projected case volume.

Request a Call Typically responds within 24 hours. No commitment required.