Tempus AI secures 510(k) for Pixel

Tempus AI announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its updated Tempus Pixel for cardiac MR image analysis.

The update reflects new software functionality designed for a comprehensive view of heart tissue. The company highlighted that the product now generates T1 and T2 inline maps directly from raw MRI data.

Unlike conventional MR images that show only brightness differences, T1 and T2 maps provide numerical values to cardiac tissue characteristics, helping clinicians detect conditions such as fibrosis, inflammation, or edema, the company said.

In its announcement, Tempus noted its larger presence in the radiology and pathology AI space. In 2022, the company acquired Arterys, which added AI-powered capabilities for lung CT, chest x-rays, and cardiac MRIs, according to the firm. Most recently, Tempus acquired the digital pathology company Paige, a deal valued at $81.3 million.

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