Tempus AI – FDA Clearance for Cardiac Imaging Platform

Tempus AI received FDA clearance for its Tempus Pixel platform, which generates T1 and T2 maps directly from MRI raw data. These maps are critical for detecting conditions such as fibrosis, edema, and inflammation—pathologies often overlooked without advanced quantitative imaging. The platform allows hospitals without specialized software or hardware to access these capabilities, democratizing access to advanced cardiac imaging.

This clearance represents a meaningful step for AI adoption in cardiology. By embedding quantitative mapping into routine workflows, Tempus hopes to shorten diagnostic timelines and improve the management of complex cardiac conditions. The announcement also demonstrates how AI vendors are focusing on specific disease-oriented use cases to drive clinical adoption.