Tempus AI, Inc. (NASDAQ:TEM) saw its stock climb 16% Thursday morning after the company announced it had secured 510(k) clearance from the U.S. Food and Drug Administration for the enhanced Tempus Pixel cardiac imaging platform.
The approval allows the AI-powered system to produce T1 and T2 inline maps for cardiac MRI analysis. These specialized maps quantify tissue characteristics, assisting clinicians in identifying issues such as fibrosis, inflammation, or edema that might otherwise go unnoticed.
Tempus Pixel can now generate these detailed maps directly from raw MRI data, even in cases where the scanner itself does not produce them, delivering comprehensive DICOM maps for advanced tissue assessment.
“This marks another important regulatory milestone for Tempus and underscores our commitment to advancing AI-driven imaging technology that is both scientifically rigorous and clinically meaningful,” said Chris Scotto DiVetta, Senior Vice President of AI Applications at Tempus.
The company has been strengthening its AI capabilities through strategic acquisitions, including Arterys in 2022 and more recently Paige, an AI firm focused on digital pathology. These acquisitions have provided additional datasets and technological enhancements, further expanding Tempus’ offerings in precision medicine.
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