Overview: What Is Viz.ai?
Viz.ai is a San Francisco-based clinical AI company founded in 2016 that pioneered FDA-regulated AI triage in radiology. Its flagship product detects large vessel occlusion (LVO) strokes from CT angiograms within seconds and automatically alerts the on-call neurointerventional team via mobile push notification — compressing the door-to-treatment time for ischemic stroke patients in measurable, clinically significant ways. Viz.ai is the only AI triage software to receive FDA De Novo clearance (DEN170073, granted 2018), and now holds 50+ FDA 510(k) clearances across stroke, hemorrhage, aneurysm, pulmonary embolism, aortic disease, cardiac, and subdural conditions — the broadest regulatory portfolio in medical imaging AI.
Where ambient scribes like Abridge or Freed are productivity tools, Viz.ai is a regulated medical device. Its outputs directly trigger clinical action, which is why FDA clearance is non-negotiable for this category and why most "AI in radiology" startups never reach Viz.ai's regulatory or deployment maturity.
Regulatory Status: The Most Important Thing
First AI triage software to receive FDA De Novo clearance (2018, DEN170073). De Novo is the FDA pathway for novel device categories where no predicate exists — Viz.ai literally created the regulatory category for AI-powered care coordination triage. Since then, Viz has accumulated 50+ 510(k) clearances for individual indications, including the most recent additions in cardiac and aortic emergencies.
Viz.ai is also one of the few AI products with a Medicare reimbursement pathway. CMS approved a New Technology Add-on Payment (NTAP) for Viz LVO, recognizing the clinical value of faster stroke triage. Reimbursement is a meaningful real-world signal of clinical utility that no marketing claim can replace.
How It Works
- AI-powered stroke detection and triage notification
- Large vessel occlusion (LVO) detection
- Intracranial hemorrhage (ICH) quantification
- Aneurysm detection
- Pulmonary embolism detection
- Aortic disease identification
- Care coordination platform with real-time alerts
- 50+ FDA-cleared algorithms
Viz.ai integrates with hospital PACS systems. When a CT angiogram is completed in the ED, Viz's AI analyzes the scan within seconds, looking for evidence of LVO, ICH, aneurysm, or other indications it has been trained to detect. If a positive finding is detected, the platform sends a push notification to the on-call neurointerventional radiologist's mobile device with a preview of the relevant imaging — bypassing the traditional pager-and-callback workflow that adds critical minutes in stroke care.
Multiple peer-reviewed studies have shown that Viz.ai deployment reduces door-to-puncture times in LVO stroke care by 30-60 minutes. For ischemic stroke, where outcomes are highly time-sensitive ("time is brain"), this translates directly into reduced disability and mortality.
Pricing
| Plan | Price | Details |
|---|---|---|
| Enterprise Platform | Contact sales — enterprise contract based on modules and hospital size | Medicare reimbursable (NTAP pathway), Per-module or platform-wide licensing, Multi-year enterprise contracts typical |
Pricing is enterprise-only, contract-based, and not publicly disclosed. Hospitals typically license modules per indication (stroke, PE, aortic, etc.) or as a platform-wide subscription with multi-year terms. The Medicare NTAP reimbursement pathway materially improves the ROI calculation for stroke centers.
Strengths and Weaknesses
Strengths
- ✓ First FDA De Novo cleared AI triage software (2018)
- ✓ 50+ FDA 510(k) clearances — broadest in imaging AI
- ✓ Medicare NTAP reimbursement pathway
- ✓ Clinically proven door-to-treatment time reduction
- ✓ Pharma partnerships with Novartis, Sanofi, Regeneron
- ✓ Multi-condition platform across neuro, cardiac, vascular
Weaknesses
- ✗ Enterprise-only pricing with no transparency
- ✗ Requires significant IT infrastructure for deployment
- ✗ Focused primarily on acute/emergency care — not outpatient
- ✗ Complex procurement for smaller hospitals
- ✗ Limited non-US market penetration
Who Should Use Viz.ai
Viz.ai is built for hospitals and stroke centers — comprehensive stroke centers, primary stroke centers, hospitals with active neurointerventional programs, and large EDs handling acute neurological and cardiovascular emergencies. The clinical and reimbursement case is strongest for LVO stroke, where the time-to-treatment effect on outcomes is most dramatic, but the broader platform now extends across acute imaging.
Viz.ai is not appropriate for outpatient radiology, small community hospitals without neurointerventional capability, ambulatory clinics, or any setting that cannot operationalize the alert workflow. The infrastructure and IT integration required is non-trivial.
Verdict
Viz.ai is the most clinically validated and regulatory-mature AI triage platform in radiology. The FDA De Novo first-mover status, the 50+ 510(k) clearances, the Medicare NTAP reimbursement, and the published outcome studies on stroke triage time make Viz.ai the gold-standard reference for what regulated clinical AI deployment should look like. We recommend Viz.ai strongly for stroke centers and hospitals with active neurointerventional programs.