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

Feb 7, 2020: U.S. FDA authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images.

This software, called Caption Guidance and is an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence in order to help the user capture images of a patient’s heart that are of acceptable diagnostic quality.

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The Caption Guidance software is indicated for use in ultrasound examination of the heart, known as two-dimensional transthoracic echocardiography (2D-TTE), for the adult patients, especially in the acquisition of standard views of the heart from different angles. These views are normally used in the diagnosis of various cardiac conditions.

“Echocardiograms are one of the most widely used diagnostic tools in the diagnosis and treatment of heart disease,” said Robert Ochs, Ph.D., deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

“Today’s marketing authorization enables medical professionals who may not be experts in ultrasonography, such as a registered nurse in a family care clinic or others, to use this tool.

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 US, killing one out of every four people, or around 647,000 Americans each year.

The term heart disease refers to several types of heart conditions. The most common type is coronary artery disease, which may cause a heart attack. Other kinds of heart disease may involve the valves in the heart, or the heart may not pump well and cause heart failure.

Cardiac diagnostic tests also essential to identify heart conditions. These can be electrocardiograms (EKG or ECG), Holter monitors and cardiac ultrasound examinations.

The software authorized is the first software authorized to guide users through cardiac ultrasound image achievements.

The Caption Guidance software was developed by using machine learning to train the software to differentiate between the acceptable and unacceptable image quality. This information formed the basis for an interactive AI user interface which provides users with prescriptive guidance on how to manoeuvre the ultrasound probe to acquire standard diagnostic quality echocardiographic images and video clips. 

AI interface provides real-time feedback on potential image quality, is capable of auto capturing video clips, and automatically saves the best video clip from a given view. Significantly, the cardiologist still reviews the images for the final assessment of the images and videos for patient evaluation.

The FDA analyzed data from two independent reports. For one test, 50 qualified sonographers scanned patients, using the Caption Guidance program and without it. In both cases, the sonographers were able to capture photographs of equal diagnostic quality. 

The other study involved teaching eight registered nurses who are not sonography experts to use the Caption Guidance program and ask them to capture regular echocardiography  pictures, followed by five cardiologists reviewing the accuracy of the pictures taken. 
The data showed that the Caption Guidance software enabled the registered nurses to acquire echocardiography images and also videos of diagnostic quality.

The FDA reviewed the device through the De Novo premarket review pathway, the regulatory pathway for the low- to moderate-risk devices of a new type. All along with the authorization, the FDA is establishing special controls for the devices of this type, including requirements related to the labeling and performance testing. https://fda.einnews.com/pr_news/509177314/fda-authorizes-marketing-of-first-cardiac-ultrasound-software-that-uses-artificial-intelligence-to-guide-user

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