Benefits
- Benefit
-
A sensitivity of 68.4% and a specificity of 99.1%
Awaiting review
- Outcome identifiers
-
Unresolved
Not reviewedUnresolved
- Category
-
Improved Task Accuracy
Awaiting review
- Status
-
Intended. The study applied the software to historical ECGs and the software guided no care, so the detection is a retrodiction that reports no realized benefit. [1]
Fully reviewed: supporting details for Status
Review date: 29 October 2026.
Sources: [1]
- Beneficiary groups
-
Organizations.
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
-
Viz HCM
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 12-lead ECGs from adults recorded on compatible ECG devices. It ran in parallel to the standard of care and did not make a diagnosis.
Awaiting review
- Human oversight
-
Unresolved
Not reviewedUnresolved
- Relation to AI
-
The study measured the accuracy of the software against cardiologist review of charts and imaging. It did not compare detection with and without the software.
Awaiting review
- AI contribution
-
Unresolved
Not reviewedUnresolved
Measurement
- Studies
-
Other. [1]
Fully reviewed: supporting details for Studies
Review date: 29 October 2026.
Sources: [1]
- Study design
-
Other. [1]
Fully reviewed: supporting details for Study design
Review date: 29 October 2026.
Sources: [1]
- Measurement
-
Retrospective standalone accuracy study against cardiologist chart and imaging review. [1]
Fully reviewed: supporting details for Measurement
Review date: 29 October 2026.
Sources: [1]
- Setting and sample
-
3,196 ECGs (291 with and 2,905 without hypertrophic cardiomyopathy) from three Massachusetts hospitals, 2017 to 2022. [1]
Fully reviewed: supporting details for Setting and sample
Review date: 29 October 2026.
Sources: [1]
- Measures
-
Sensitivity, specificity and positive predictive value. [1]
Fully reviewed: supporting details for Measures
Review date: 29 October 2026.
Sources: [1]
- Comparison
-
Cardiologist review of the chart and imaging. [1]
Fully reviewed: supporting details for Comparison
Review date: 29 October 2026.
Sources: [1]
- Results
-
Sensitivity 68.4%, specificity 99.1%, PPV 13.7% at a prevalence of 0.2%. [1]
Fully reviewed: supporting details for Results
Review date: 29 October 2026.
Sources: [1]
- Additional value from AI
-
Not isolated. [1]
Fully reviewed: supporting details for Additional value from AI
Review date: 29 October 2026.
Sources: [1]
- Limitations
-
Retrospective; one cardiologist set most labels; about one in three patients with the disease was missed. [1]
Fully reviewed: 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: Viz.ai (retrospective study on ECGs from three Massachusetts hospitals).Awaiting review
- Jurisdictions
-
Benefit: Boston area and Salem, Massachusetts,
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
-
The patient is 18 or older and has no implanted pacemaker. A positive result leads to follow-up testing for hypertrophic cardiomyopathy.
Awaiting review
- Replication attempts
-
Unresolved
Not reviewedUnresolved
- 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-0631-source-0001
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: one independent regulatory document. The cited evidence includes no independent study or report. [1]
Fully reviewed: supporting details for Evidence strength
Review date: 29 October 2026.
Sources: [1]
- Missing evidence
-
Unresolved
Not reviewedUnresolved
Grades
- Assessed benefits
-
Organizations.
Awaiting review
- Depth
-
The revised record no longer states this information.
Not reviewedUnresolved: supporting details for Depth
The record revision removed the mapped value.
- Reasons
-
Organizations: The sensitivity and specificity come from historical records, and no patient was referred for follow-up because of the software.
Awaiting review
- Observed or intended
-
Intended. The study applied the software to historical ECGs and the software guided no care, so the detection is a retrodiction that reports no realized benefit. [1]
Fully reviewed: supporting details for Observed or intended
Review date: 29 October 2026.
Sources: [1]
- 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 regulatory review of a standalone accuracy study. [1]
Fully reviewed: 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 reviewedUnresolved: supporting details for Related entries
Compared with the incidents in the AI Incident Database snapshot of 26 October 2026.
- Field
-
Healthcare.
Awaiting review
- Purpose
-
Viz HCM was built to detect signs of hypertrophic cardiomyopathy on 12-lead ECGs and identify patients for follow-up. The measured detection is that purpose.
Awaiting review
- Dates
-
Source published: 3 August 2023. Updated: 29 October 2026.
Awaiting review
- Stage
-
The system was tested in a laboratory. A retrospective study on historical ECGs; the software did not guide care. [1]
Fully reviewed: supporting details for Stage
Review date: 29 October 2026.
Sources: [1]
- Version
-
SHA-256: 99ec3af7880c…
Awaiting review: 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
-
2 revisions. Latest: 29 October 2026.
Awaiting review
Sources
-
Regulatory document Independent author
U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for Viz HCM (DEN230003): decision summary. Granted 2023-08-03.
The ability to provide additional detection of and insight into a disease that is relatively uncommon and difficult to diagnose in subjects represents a benefit to the intended patient population.