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A First: FDA Clears an AI-Assisted Cardiac MRI Scanner

AI-Assisted Cardiac MRI Scanner

In a first, the FDA has cleared a cardiac MRI scanner that’s assisted by artificial intelligence (AI). This comes after a study published in the New England Journal of Medicine back in June.

The AI was developed by a team in Los Altos, CA; the product is called HeartVista’s Cardiac Package and is described by Radiology Business as a “one-click heart MRI examination tool.” The June study’s results found that noninvasive, myocardial perfusion cardiovascular MRI was equally effective as invasive fractional-flow reserve, which is considered the current standard for investigating consistent chest pain. 

In a statement, HeartVista CEO Itamar Kandel said “We believe [HeartVista’s Cardiac Package] will elevate the standard of care for cardiac imaging, enhance patient experience and access, and improve patient outcomes.

In late October, however, HeartVista explained that despite how helpful their tool could be, it has barely been put to use. They speculated that the reason behind this is largely threefold, though there may be others: lofty costs, extensive scan times, and few trained technologists. 

The Cardiac Package offered by HeartVista uses AI to “prescribe the standard number of cardiac views with one click of a button.” The AI can also determine if the quality of the image capture is not up to the acceptable threshold, and if so, it tells the MRI operator(s) to retake images. Additionally, the AI offers preliminary measurements of the left ventricle’s volumes, mass, and function.

HeartVista announced it plans to showcase its novel technology in early December at the annual RSNA meeting in Chicago, at the AI Showcase Theater.