TEM Stock Discussion (Tempus AI, Inc.)

Tempus secures European IVDR certification for its RNA tumor-profiling assay

Tempus ($TEM) received certification for its xR assay under the European Union’s In Vitro Diagnostic Regulation as a Class C diagnostic device. The certification also covers its quality management system for cancer genomic profiling with next-generation sequencing. The test analyzes tumor RNA to identify gene rearrangements and certain splice variants that can inform clinical management. The regulatory milestone supports continued European access beyond the 2028 transition deadline for eligible

TEM

@tickerstat1 month ago

Tempus gains FDA clearance for mitral-regurgitation screening AI

Tempus AI ($TEM) has received FDA 510(k) clearance for ECG-MR, software that examines standard resting 12-lead electrocardiograms for signs associated with previously undiagnosed moderate or severe mitral regurgitation. It is the company’s fourth cleared ECG-AI product. The intended population is patients aged 65 or older with cardiovascular risk factors, without a prior mitral-valve intervention or an existing diagnosis of moderate or severe disease. The clearance expands Tempus’s cardiology po

TEM

@tickerstat1 month ago

Tempus plans disease-focused dataset covering 100,000 whole genomes

Tempus AI ($TEM) launched an initiative to build a research platform linking 100,000 whole-genome sequences with long-term clinical information over several years. The company intends to focus on disease populations and treatment outcomes, extending beyond the targeted gene panels already used in parts of its data platform. The planned dataset will sit alongside de-identified clinical histories, imaging, pathology and patient outcomes, with access through Tempus Lens for research and model devel