DiA gets FDA nod, CE Mark for AI-based ultrasound tools

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Echocardiography image analysis software developer DiA Imaging Analysis has received U.S. Food and Drug Administration (FDA) 510(k) clearance and the European CE Mark for use of its artificial intelligence (AI)-based ultrasound algorithms for patients with COVID-19.

LVivo RV is an AI-based algorithm for automated analysis of the heart's right ventricle and can be used to diagnose and monitor right heart ailments in acute and chronic patients, including those with COVID-19. LVivo Bladder uses AI to deliver automated bladder volume measurements on ultrasound devices, which minimizes scan time and infection risk, according to DiA.

DiA's new AI-based ultrasound analysis tool LVivo RV. Image courtesy of DiA.DiA's new AI-based ultrasound analysis tool LVivo RV. Image courtesy of DiA.

Both algorithms are available as part of DiA's LVivo Toolbox, which now includes six FDA/CE-cleared AI-powered ultrasound algorithms. What's more, LVivo Bladder extends DiA's range of applications from its core market of cardiac ultrasound into abdominal imaging.

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