Caption Health https://captionhealth.com, a medical AI company, recently announced that the FDA has authorized the marketing of software to assist medical professionals using cardiac ultrasound, or echocardiography images.
The software called “Captain Guidance” is an accessory to use with compatible diagnostic ultrasound systems that includes AI. The AI interface provides real-time feedback on potential image quality, able to auto-capture video clips, and automatically saves the best video clips acquired from a particular view. The cardiologist still reviews the images for a final assessment of the images and views videos for patient evaluation.
The “Captain Guidance” software is indicated for use in ultrasound exams of the heart, known as two-dimensional transthoracic echocardiography (2D-TTE), for adult patients. This is to be used specifically to obtain standard views of the heart from different angles to diagnose various cardiac conditions.
According to Robert Ochs, PhD, Deputy Director for the Office of In-Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health, “Today’s marketing authorization, enables medical professionals who may not be experts in ultrasonography use this tool.”
There are several cardiac diagnostic tests available to identify heart conditions such as EKG or ECG, Holter monitors, and cardiac ultrasound exams. This tool demonstrates the potential for AI and machine learning technologies to increase access to safe and effective cardiac diagnostics.
The software has the potential to be used with other ultrasound imaging systems that have technical specifications consistent with the range of ultrasound systems used as part of the development and testing.