Tempus receives FDA clearance for updated cardiac imaging device

Tempus AI, Inc. (NASDAQ: TEM) received 510(k) clearance from the U.S. Food and Drug Administration for its updated Tempus Pixel cardiac imaging platform, the company announced. The clearance allows the device to generate T1 and T2 inline maps for cardiac MR image analysis.

The AI-powered platform provides automated reporting of cardiac MR images for flow visualization, functional analysis, and tissue characterization. The updated functionality enables Tempus Pixel to generate T1 and T2 inline maps directly from raw MRI data, even when the scanner does not produce them.

T1 and T2 maps provide numerical values for cardiac tissue characteristics, helping clinicians detect conditions such as fibrosis, inflammation, or edema. The device calculates values at every pixel across the image to create DICOM maps for 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.

Tempus has developed algorithms across radiology and pathology through strategic acquisitions. In 2022, the company acquired Arterys, incorporating AI-powered tools for analyzing imaging data including lung CT scans, chest X-rays, and cardiac MRIs. The company recently acquired Paige, an AI company specializing in digital pathology, bringing a dataset of almost 7 million clinically annotated pathology slides.

The information is based on a company press release.

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