FDA clears AI-powered cardiac imaging platform
Tempus AI, a Chicago-based tech company focused on bringing artificial intelligence (AI) to a wide variety of healthcare specialties, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its updated Tempus Pixel cardiac imaging platform.
Clinicians use Tempus Pixel view and automate the reporting of cardiac magnetic resonance (MR) images. As part of this newly approved update, users can now generate T1 and T2 maps from raw data, providing detailed evaluations that help with the diagnosis of fibrosis, inflammation, edema and other conditions. Even when the actual scanner is unable to produce these maps, Tempus Pixel can step in and calculate the necessary values.
“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,” Chris Scotto DiVetta, senior vice president of AI applications at Tempus, said in a prepared statement. “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 already developed multiple advanced AI models to be used in radiology and pathology. The company has also made a series of acquisitions designed to expand its AI imaging portfolio. The most recent of those deals was the acquisition of Paige, an AI company focused on digital pathology, for $81.25 million in August.
