DiA Imaging Analysis Receives 510(k) Clearance for Cardiac Ultrasound AI

DiA Imaging Analysis has earned 510(k) marketing clearance from the FDA for its artificial intelligence (AI)-based LVivo Seamless cardiac ultrasound software that selects optimal cardiac ultrasound views.

The software can automatically pick the best cardiac ultrasound views out of 40 to 60 views in standard echocardiogram exams. The AI algorithm can assess images from any ultrasound device and works with any radiology image viewer, the company said.

The newly cleared software works with DiA’s other LVivo cardiac analysis products, including LVivo EF, which automatically calculates ejection fraction — a measurement of how much blood the heart’s left ventricle pumps out with each contraction.