Caption Guidance let nurses take usable heart scans

In FDA's review of Caption Guidance, eight nurses new to echocardiography scanned 240 patients with AI guidance; cardiologists judged left ventricular size assessable in 98.8% of exams.

2
Benefit status
Reported
Evidence
Found by a court or regulator
Observed
Sources
2 publications
Download data CiteSuggest a correction

Benefits

Benefit

Left ventricular size in 98.8% of exams

Awaiting review

Outcome identifiers

Unresolved

Not reviewedUnresolved

Category

Improved Accessibility

Awaiting review

Status

Reported benefit

Awaiting review

Beneficiary groups

Organizations. Society.

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

Caption Guidance

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

Nurses received training on the software before scanning. Scans used a Terason ultrasound system with the guidance software. Patients were adults scheduled for a clinically indicated echocardiogram.

Awaiting review

Human oversight

Unresolved

Not reviewedUnresolved

Relation to AI

The study compared guided nurse scans with unguided sonographer scans. It had no arm of nurses scanning without guidance, so the contribution of the software is not isolated.

Awaiting review

AI contribution

Unresolved

Not reviewedUnresolved

Measurement

Studies

Controlled observational. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Study design

Controlled observational. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Measurement

Paired exams by guided nurses and unguided sonographers, rated by five blinded cardiologists. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Setting and sample

Eight nurses, 240 patients, two US academic centers. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Measures

Share of exams with sufficient quality for four clinical assessments. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Comparison

Unguided sonographer exams on the same patients. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Results

98.8% for LV size, LV function and effusion; 92.5% for RV size. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Additional value from AI

Not isolated. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Limitations

No unguided nurse arm; some views reached diagnostic quality in fewer than 70% of clips. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Denominators

One guided exam per patient. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Materials for replication

None public. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

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: Caption Health, Inc. (listed as Bay Labs, Inc. In the FDA database). Operator: Northwestern Memorial Hospital and Minneapolis Heart Institute.

Awaiting review

Jurisdictions

Benefit: Chicago, Illinois, and Minneapolis, Minnesota, 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 cardiac specialist reviews the acquired images. The ultrasound system is compatible with the software.

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-0625-source-0001–0002

Awaiting review

Citations

Numbered references below.

Awaiting review

Language

Unresolved

Not reviewedUnresolved

Source relationships

Independent, Developer

Awaiting review

Original evidence

Unresolved

Not reviewedUnresolved

Access and versions

Unresolved

Not reviewedUnresolved

Supported findings

Unresolved

Not reviewedUnresolved

Evidence strength

Found by a regulator. Sources: one independent regulatory document and the makers' peer-reviewed study. The cited evidence includes no independent study or report. [1] [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [1] [2]

Missing evidence

Unresolved

Not reviewedUnresolved

Grades

Assessed benefits

Organizations. Society.

Awaiting review

Depth

Organizations: 2. Society: Not assessed.

Awaiting review

Reasons

Organizations: Nurses with no echocardiography experience produced exams that cardiologists judged sufficient to assess left ventricular size in 98.8% of patients. Society: FDA reviewers expect that patients would gain faster access to echocardiography, but the sources report no realized outcome for society beyond the two-site study.

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 regulatory review of a prospective clinical study. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Field

Healthcare.

Awaiting review

Purpose

Caption Guidance was built to help medical professionals, including those without echocardiography training, acquire standard cardiac ultrasound views. The measured benefit is that purpose.

Awaiting review

Dates

Observed: May 2019. Updated: 29 October 2026.

Awaiting review

Stage

The system was used in a pilot. A prospective pivotal study in two hospitals before authorization. [2]

Fully reviewed

Review date: 29 October 2026.

Sources: [2]

Version

SHA-256: d6fcdcaf4341…

Awaiting review

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

  1. Peer-reviewed study Developer

    Narang A, Bae R, Hong H, et al. Utility of a deep-learning algorithm to guide novices to acquire echocardiograms for limited diagnostic use. JAMA Cardiology 2021;6(6):624-632.

  2. Regulatory document Independent author

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for Caption Guidance (DEN190040): decision summary. Granted 2020-02-07.

Collections: Scrutiny and findings.

Cite this case

BibTeX Download BibTeX

Version d6fcdcaf4341, archived in the edition of 29 October 2026

Benefit marks

Depth

The number and color show the depth of a benefit.

  1. A convenience, or time or money saved.
  2. A measurable improvement in a result or ability.
  3. A lasting change, an ability restored, or a risk removed.
  4. A serious harm averted or a serious condition resolved in time.
  5. A life or livelihood preserved, or a change documented across a population.

Beneficiary

  • Circle: a person
  • Square: an organization
  • Triangle: society

Evidence

  • Solid. A court or regulator found a benefit, or researchers independently studied it.

  • Hatched. Independent reporting.

  • Outline. Claimed by the parties. Only the people or organizations involved, or sources whose independence has not been assessed, support the benefit.

The fill changes with the evidence. The depth color stays the same.

How benefits are assessed