FDA Clears Updated Tempus Pixel Device

Tempus AI Inc. has received U.S. Food and Drug Administration 510(k) clearance for its updated Tempus Pixel, an artificial intelligence (AI)-powered cardiac imaging platform. The update allows clinicians to generate T1 and T2 inline maps, thus enhancing the device’s cardiac MR image analysis capabilities.

Tempus Pixel provides advanced viewing and automated cardiac MR image reporting, thereby 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, according to the company.

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.

“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. “With inline maps generated by Tempus Pixel, cardiologists and radiologists gain a comprehensive view of heart tissue, enabling deeper insights into cardiac health and helping them deliver more precise, personalized care to their patients.”

Tempus has developed and deployed a suite of advanced algorithms across radiology and pathology, helping physicians deliver more precision, personalized care. In 2022, Tempus acquired Arterys, incorporating its AI-powered tools for analyzing imaging data—ranging from lung computed tomography scans and chest X-rays to cardiac MRIs—into Tempus’ platform. Most recently, Tempus acquired Paige, an AI company specializing in digital pathology, bringing a proprietary dataset of almost 7 million clinically annotated, de-identified pathology slides to accelerate Tempus’ efforts.

Tempus is a technology company advancing precision medicine by practically applying artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics.