Tempus Inc. has received 510(k) clearance from the U.S. Food and Drug Administration for its Tempus ECG-Low EF software, an artificial intelligence-powered tool designed to identify adults aged 40 and older who may have a low left ventricular ejection fraction (LVEF) of 40% or less, which is a potential indicator of heart failure. This marks the company's second FDA-cleared ECG-AI device, following its earlier approval for the ECG-AF software. The new software is intended to assist in flagging at-risk patients but is not approved for monitoring or as a standalone diagnostic tool. Following the announcement, Tempus shares saw a pre-market increase of approximately 3.7%. Separately, Stereotaxis Inc. obtained FDA clearance for its MAGiC Sweep catheter, the world's first robotically navigated high-density electrophysiology mapping catheter. This device aims to improve cardiac ablation procedures by providing efficient, detailed, and precise arrhythmia mapping with extended reach and anatomical accuracy. Stereotaxis shares rose by more than 15% in pre-market trading after the clearance was announced.