Caption Guidance
Caption Health
Real-time guidance software that instructs the user on probe manipulation to obtain diagnostic-quality cardiac views, authorized to allow use by clinicians who are not trained sonographers.
At A Glance
- Manufacturer
- Caption Health
- Medical specialty
- Cardiology
- Clearance route
- De Novo
- Year authorized
- 2020
- Modality
- Echocardiography
- Role in workflow
- Acquisition guidance
Every other device on this list operates on an image after it exists. Caption Guidance operates on the acquisition, which is where echocardiography actually fails. The scarce resource in cardiac ultrasound is not interpretation. It is the person who can obtain a diagnostic view.
Authorizing software to make a non-sonographer capable of acquiring a diagnostic study is a genuinely different regulatory proposition, and it is why this went through De Novo.
Where It Is Used
- Point-of-care echocardiography by non-cardiologists
- Nurse and emergency clinician image acquisition
- Rural and resource-limited cardiac assessment
Limitations Worth Knowing
Guidance improves acquisition, not interpretation, and expanding who can obtain a study also expands who obtains a study of uncertain quality. The clinical governance question is what happens to a borderline image acquired by a novice user when no expert reviews it.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.