Tempus Receives FDA 510(k) Clearance for Updated Tempus Pixel Device
Tempus, a technology company advancing precision medicine, announced that it has received U.S. FDA Special 510(k) clearance for its updated Tempus Pixel device. This clearance marks a significant milestone for Tempus and underscores its commitment to advancing AI-driven imaging technology in healthcare.
Advancing Precision Medicine with AI
Tempus has been actively developing and deploying a suite of advanced algorithms across radiology and pathology. These efforts are designed to help physicians deliver more precise and personalized care to their patients. The company's strategic acquisitions, including Arterys in 2022 and, more recently, Paige, have further strengthened its presence in these fields. The acquisition of Paige brings a proprietary dataset of nearly 7 million clinically annotated, de-identified pathology slides, accelerating Tempus' AI efforts.
The Significance of Tempus Pixel's New Functionality
The updated Tempus Pixel device can now generate T1 and T2 inline maps directly from raw MRI data, even when the scanner doesn't natively produce them. This capability allows cardiologists and radiologists to gain a comprehensive view of heart tissue, enabling deeper insights into cardiac health. The device calculates 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."
How Tempus Pixel Enhances Cardiac Imaging
Traditional MR images primarily display brightness differences. T1 and T2 maps, however, provide precise numerical values reflecting cardiac tissue characteristics. This allows clinicians to better detect conditions such as fibrosis, inflammation, or edema, which might otherwise go undetected. By generating these maps directly from raw MRI data, Tempus Pixel provides a more detailed and comprehensive tissue assessment.
About Tempus
Tempus is dedicated to advancing precision medicine through the application of artificial intelligence in healthcare. With one of the world's largest libraries of multimodal data, and an operating system designed to make that data accessible and useful, Tempus delivers AI-enabled precision medicine solutions. The company facilitates the discovery, development, and delivery of optimal therapeutics, ultimately aiming to improve patient outcomes.
Forward-Looking Statements
It is important to note that this announcement contains forward-looking statements regarding the expected outcomes and benefits of Tempus Pixel. These statements are subject to risks and uncertainties as outlined in Tempus' filings with the SEC, including their latest 10-K report. Investors are cautioned not to rely on these statements as predictions of future events.
