Overview

• The FDA granted 510(k) clearance for the updated Tempus Pixel platform, enabling generation of pixel‑wise T1 and T2 maps directly from raw cardiac MRI data even on scanners that do not natively produce them.
• Tempus Pixel includes advanced viewing and automated reporting designed to improve efficiency and accuracy in flow visualization, functional analysis, and tissue characterization.
• Tempus says the numerical maps can help clinicians detect features such as fibrosis, inflammation, or edema that may be less apparent on conventional MR images.
• Senior vice president Chris DiVetta called the clearance an important regulatory milestone for the company’s AI-driven imaging efforts.
• Tempus shares rose roughly 13%–15%, hitting intraday highs near $91 and closing at a seven‑month high, as investors weighed the clearance alongside the firm’s expanded imaging footprint and a raised 2025 revenue outlook near $1.26 billion.