FDA clears Heartvista’s AI-assisted cardiac MRI tool

Editor's Note

Heartvista (Los Altos, California) has obtained clearance from the Food and Drug Administration (FDA) for its artificial intelligence (AI)-assisted One Click autonomous MRI acquisition software for cardiac ischemia exams, the October 30 BioWorld MedTech reports.

Integrated with existing MRI scanners, the software uses AI to guide image acquisition, and with a single click, operators can perform an exam in less than 15 minutes, compared with 90 minutes for a traditional MRI.

The software provides the standard cardiac views in about 10 minutes while the patient breathes naturally.

The software has an artifact detection neural network that alerts operators to poor image quality, prompting the operator to repeat those images if necessary.