Special 510(k) Clearance for Updated Tempus Pixel Device

 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its updated Tempus Pixel, an AI-powered cardiac imaging platform. This update allows the generation of T1 and T2 inline maps, further enhancing the device’s capabilities for cardiac MR image analysis.

Tempus Pixel provides advanced viewing and automated reporting of cardiac MR images, improving efficiency and accuracy in flow visualization, functional analysis, and tissue characterization. AI-enabled radiology, like Tempus Pixel, enhances medical imaging by rapidly analyzing scans, highlighting subtle abnormalities, and generating consistent, actionable insights. By improving accuracy and efficiency, it empowers clinicians to make faster, more informed decisions and deliver personalized patient care.

Unlike conventional MR images that show only brightness differences, T1 and T2 maps provide precise numerical values to cardiac tissue characteristics, helping clinicians detect conditions such as fibrosis, inflammation, or edema, that may otherwise go undetected. With its newly cleared functionality, Tempus Pixel can now generate T1 and T2 inline maps directly from raw MRI data, even when the scanner itself does not produce them, calculating values at every pixel across the image to create detailed DICOM maps for comprehensive tissue assessment.

https://www.businesswire.com/news/home/20250911224717/en/Tempus-Receives-U.S.-FDA-Special-510k-Clearance-for-Updated-Tempus-Pixel-Device