Key Takeaways Tempus AI gained FDA clearance for its RNA-based Tempus xR IVD device aiding drug development. The updated Tempus Pixel earned FDA nod for new T1 and T2 mapping in cardiac MR image analysis. Tempus AI received approval for ECG-Low EF, its second FDA-cleared ECG-AI tool for heart diagnostics.In the first nine months of 2025, Tempus AI Inc. (TEM) achieved several key regulatory milestones that strengthened its position in AI-driven diagnostics. In September 2025, the company received FDA 510(k) ...