Tempus receives FDA clearance for updated cardiac imaging device
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Tempus Receives U.S. FDA Special 510(k) Clearance for Updated Tempus Pixel Device
September 11, 2025 8:30 AM EDTCHICAGO--(BUSINESS WIRE)-- Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its updated Tempus Pixel, an AI-powered cardiac imaging platform. This update allows the generation of T1 and T2 inline maps, further enhancing the devices capabilities for cardiac MR image analysis.
Tempus Pixel provides advanced viewing and automated reporting of cardiac MR images, improving efficiency and accuracy in flow visualization, functional analysis, and tissue characterization. AI-enabled... More
