FDA Okays Marketing Of Ultrasound Software To Examine Heart

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The U.S. Food and Drug Administration or FDA granted marketing authorization for the first cardiac ultrasound software that uses artificial intelligence (AI) to help the user capture images of a patient's heart that are of acceptable diagnostic quality. These images will typically help in the diagnosis of various cardiac conditions of patients.

The software called "Caption Guidance" is an accessory to compatible diagnostic ultrasound systems. It will help medical professionals in acquiring cardiac ultrasound or echocardiography images. The FDA granted marketing authorization of the software to Caption Health Inc.

The Caption Guidance software is currently approved to be used with a specific FDA-cleared diagnostic ultrasound system produced by Teratech Corp. It can also potentially be used with other compatible ultrasound imaging systems.

The Caption Guidance software is indicated for use in ultrasound examination of the heart, known as two-dimensional transthoracic echocardiography (2D-TTE), for adult patients, specifically in the acquisition of standard views of the heart from different angles.

This software will also enable medical professionals who may not be experts in ultrasonography, such as a registered nurse in a family care clinic or others.

The software provides prescriptive guidance to users on how to maneuver the ultrasound probe to acquire standard echocardiographic images and video clips of diagnostic quality.

The AI interface provides real-time feedback on potential image quality and automatically saves the best video clip acquired from a particular view for the cardiologist to review and provide a final assessment of the images and videos for patient evaluation.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory means for low- to moderate-risk devices of a new type.

Heart disease is the leading cause of death in the United States, killing one out of every four people, or approximately 647,000 Americans each year, according to the Centers for Disease Control and Prevention.

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