Benefits
- Benefit
-
The median time to notification was 4.31 minutes
Awaiting review
- Outcome identifiers
-
Unresolved
Not reviewedUnresolved
- Category
-
Reduced Task Time
Awaiting review
- Status
-
Reported benefit
Awaiting review
- Beneficiary groups
-
Organizations. People.
Awaiting review
- Beneficiaries
-
Unresolved
Not reviewedUnresolved
- Reach
-
Unresolved
Not reviewedUnresolved
- Distribution and access
-
Unresolved
Not reviewedUnresolved
- Duration
-
Unresolved
Not reviewedUnresolved
- Expected?
-
Yes
Awaiting review
- Costs and harms
-
Unresolved
Not reviewedUnresolved
AI system
- System
-
ContaCT (Viz LVO algorithm with Viz Hub and Viz View)
Awaiting review
- Model
-
This is an explicit unresolved assignment: the sources on record do not settle this question.
Not reviewedUnresolved
- Release
-
Unresolved
Not reviewedUnresolved
- Provider
-
Unresolved
Not reviewedUnresolved
- Role
-
Unresolved
Not reviewedUnresolved
- Configuration
-
Unresolved
Not reviewedUnresolved
- Inputs and outputs
-
Unresolved
Not reviewedUnresolved
- Autonomy
-
Unresolved
Not reviewedUnresolved
- Workflow
-
The software analyzed CT angiograms of the brain and alerted specialists in parallel with the radiology read. Specialists received alerts and images through the Viz Hub and Viz View mobile tools.
Awaiting review
- Human oversight
-
Unresolved
Not reviewedUnresolved
- Relation to AI
-
The FDA comparison used past scans, so the alerts did not reach a treating team. The routine-use data have no comparison group, and the hospital before and after comparisons do not rule out other changes to stroke care.
Awaiting review
- AI contribution
-
Unresolved
Not reviewedUnresolved
Measurement
- Studies
-
Study 1: before/after. Study 2: controlled observational. [1]
Fully reviewedDetails: supporting details for Studies
Review date: 29 October 2026.
Sources: [1]
- Study design
-
Study 1: before/after. Study 2: controlled observational. [1]
Fully reviewedDetails: supporting details for Study design
Review date: 29 October 2026.
Sources: [1]
- Measurement
-
Study 1: Hospital records of door-to-puncture times before and after ContaCT implementation, as reported by the applicant. Study 2: Comparison of ContaCT notification times with recorded usual-care notification times on past scans, as cited by CMS. [1]
Fully reviewedDetails: supporting details for Measurement
Review date: 29 October 2026.
Sources: [1]
- Setting and sample
-
Study 1: SkyRidge (32 patients), Wellstar (120 patients), Methodist Le Bonheur (46 patients), Mount Sinai (42 patients). Study 2: Past scans from the study submitted for FDA authorization. [1]
Fully reviewedDetails: supporting details for Setting and sample
Review date: 29 October 2026.
Sources: [1]
- Measures
-
Study 1: Door-to-puncture time; time to specialist notification. Study 2: Time from CT angiogram to specialist notification. [1]
Fully reviewedDetails: supporting details for Measures
Review date: 29 October 2026.
Sources: [1]
- Comparison
-
Study 1: Patients treated before ContaCT, or with occlusions that ContaCT did not flag. Study 2: Usual-care notification time. [1]
Fully reviewedDetails: supporting details for Comparison
Review date: 29 October 2026.
Sources: [1]
- Results
-
Study 1: Average door-to-puncture reductions of 24, 30 and 44 minutes; median notification 4.31 minutes in 4,763 patients. Study 2: 7.32 minutes against 58.72 minutes mean. [1]
Fully reviewedDetails: supporting details for Results
Review date: 29 October 2026.
Sources: [1]
- Additional value from AI
-
Study 1: Not isolated in the hospital cohorts. Study 2: About 51 minutes earlier notification. [1]
Fully reviewedDetails: supporting details for Additional value from AI
Review date: 29 October 2026.
Sources: [1]
- Limitations
-
Study 1: Small single-site cohorts; data supplied by the applicant; CMS earlier raised confounding concerns. Study 2: Time to notification is a process measure; patient outcomes were not measured in this study. [1]
Fully reviewedDetails: supporting details for Limitations
Review date: 29 October 2026.
Sources: [1]
Money
- Kind of value
-
The kind of monetary value is unclear.
Not reviewedUnresolved
- Amount
-
The monetary value is not established.
Not reviewedUnresolved
- Currency and prices
-
The currency and price basis are unclear.
Not reviewedUnresolved
- Period and unit
-
The period and unit of the monetary estimate are unclear.
Not reviewedUnresolved
- Realization
-
Whether the monetary value was realized is unclear.
Not reviewedUnresolved
- Recipients and payers
-
The recipients and payers are unclear.
Not reviewedUnresolved
- Gross or net
-
Whether the monetary figure includes costs is unclear.
Not reviewedUnresolved
- Included costs
-
The costs included in the estimate are unclear.
Not reviewedUnresolved
- Comparison
-
The financial comparison is not established.
Not reviewedUnresolved
- Method
-
The method used to calculate monetary value is unclear.
Not reviewedUnresolved
- Return and payback
-
The return on investment or payback period is not established.
Not reviewedUnresolved
People and places
- Participants
-
Developer:
Viz.ai, Inc. Operator: US hospitals using ContaCT, including SkyRidge Medical Center, Wellstar, Methodist Le Bonheur Healthcare and Mount Sinai Health System.Awaiting review
- Jurisdictions
-
Benefit:
United States. Developer:
United States. Operator:
United States.Awaiting review
- Ownership and control
-
Unresolved
Not reviewedUnresolved
- Dependencies
-
Unresolved
Not reviewedUnresolved
- Cross-border connections
-
Unresolved
Not reviewedUnresolved
- Geopolitical implications
-
The geopolitical implications are unclear.
Not reviewedUnresolved
Follow-up
- Conditions for replication
-
A thrombectomy team is ready to act on alerts. Scans meet the device's acquisition requirements.
Awaiting review
- Replication attempts
-
3 follow-up entries. Benefit recurred: 3.
Awaiting review
- Later findings
-
Unresolved
Not reviewedUnresolved
- Availability
-
Unresolved
Not reviewedUnresolved
- Institutional decision
-
A relevant institutional decision has not been established.
Not reviewedUnresolved
- Grounds
-
The grounds for an institutional decision are unclear.
Not reviewedUnresolved
- Action and result
-
The result of an institutional decision is not established.
Not reviewedUnresolved
- Success criterion
-
The criterion for a successful institutional decision is unclear.
Not reviewedUnresolved
Evidence
- Source numbers
-
AIBD-0651-source-0001–0002
Awaiting review
- Citations
-
Numbered references below.
Awaiting review
- Language
-
Unresolved
Not reviewedUnresolved
- Source relationships
-
Independent
Awaiting review
- Original evidence
-
Unresolved
Not reviewedUnresolved
- Access and versions
-
Unresolved
Not reviewedUnresolved
- Supported findings
-
Unresolved
Not reviewedUnresolved
- Evidence links
-
Unresolved
Not reviewedUnresolved
- Evidence strength
-
Found by a regulator. Sources: two independent regulatory documents. The cited evidence includes no independent study or report. [1] [2]
- Missing evidence
-
Unresolved
Not reviewedUnresolved
Grades
- Assessed benefits
-
Organizations. People.
Awaiting review
- Depth
-
Organizations: 2. People: 2.
Awaiting review
- Reasons
-
Organizations: Viz.ai data showed a median of 4.31 minutes from scan to specialist notification across 4,763 patients in routine use. People: Hospital comparisons reported average reductions in door-to-puncture time of 24, 30 and 44 minutes for thrombectomy patients.
Awaiting review
- Observed or intended
-
Unresolved
Not reviewedUnresolved
- Rubric
-
Unresolved
Not reviewedUnresolved
- Assessor and date
-
Unresolved
Not reviewedUnresolved
- Alternative assessments
-
Unresolved
Not reviewedUnresolved
- Fill
-
Found by a regulator
Awaiting review
Entry details
- Kind
-
The case describes an evaluation or a study. A payment regulator's determination based on several studies and deployment data. [1]
Fully reviewedDetails: supporting details for Kind
Review date: 29 October 2026.
Sources: [1]
- Related entries
-
No incident in the AI Incident Database snapshot of 26 October 2026 concerns the same kind of system harming the same kind of stakeholder.
Partly reviewedUnresolvedDetails: supporting details for Related entries
Compared with the incidents in the AI Incident Database snapshot of 26 October 2026.
- Field
-
Healthcare.
Awaiting review
- Purpose
-
ContaCT was built to alert a stroke specialist to a suspected large vessel occlusion in parallel with the usual radiology read. Faster notification is that purpose.
Awaiting review
- Dates
-
Source information as of: October 2018. Updated: 29 October 2026.
Awaiting review
- Stage
-
The system was in routine use. ContaCT was in routine hospital use from October 2018; CMS weighed six months of routine-use data. [1]
Fully reviewedDetails: supporting details for Stage
Review date: 29 October 2026.
Sources: [1]
- Version
-
SHA-256: 1d3e16864102…
Awaiting reviewDetails: supporting details for Version
SHA-256 of the public case, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.
References
- Other identifiers
-
Unresolved
Not reviewedUnresolved
- Category mappings
-
Unresolved
Not reviewedUnresolved
- Citable summary
-
Unresolved
Not reviewedUnresolved
- Revisions
-
1 revision. Latest: 29 October 2026.
Awaiting review
Sources
-
Regulatory document Independent author
we have determined that ContaCT represents a substantial clinical improvement over existing technologies because, based on the information provided by the applicant, the technology shortens time to notification
-
Regulatory document Independent author
U.S. Food and Drug Administration. De Novo classification request for ContaCT (DEN170073): decision summary. 13 February 2018.
The clinical benefit is that the device identifies patients who may benefit from rapid intervention by a neurovascular specialist.
Collections: Scrutiny and findings.