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FDA Authorizes Marketing of First Cardiac Ultrasound Software That Uses Artificial Intelligence to Guide User

Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images.

This is especially important because it demonstrates the potential for artificial intelligence and machine learning technologies to increase access to safe and effective cardiac diagnostics that can be life-saving for patients.” According to the Centers for Disease Control and Prevention, 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.

This knowledge formed the basis of an interactive AI user interface that provides prescriptive guidance to users on how to maneuver the ultrasound probe to acquire standard echocardiographic images and video clips of diagnostic quality.

The Caption Guidance software currently can be used with a specific FDA-cleared diagnostic ultrasound system produced by Teratech Corporation, with 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.

The other study involved training eight registered nurses who are not experts in sonography to use the Caption Guidance software and asking them to capture standard echocardiography images, followed by five cardiologists assessing the quality of the images acquired.

This February, the FDA is hosting a public workshop titled “Evolving Role of Artificial Intelligence (AI) in Radiological Imaging” and seeks to discuss emerging applications of AI in radiological imaging, including AI devices intended to automate the diagnostic radiology workflow, as well as guided image acquisition.

This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

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