Clinical data, tests and algorithms
Tempus develops clinical and research products spanning assays, data tools, models and AI applications. That portfolio makes it an intermediary between patient information and tools used by clinicians and researchers, with regulatory status depending on the particular product. [1]
A specific machine-learning device decision
FDA cleared Tempus ECG-AF on June 21, 2024. The software analyzes eligible patients’ resting 12-lead ECG recordings for signs associated with atrial fibrillation or flutter within the following twelve months. Its cleared population is age 65 and older, with additional eligibility conditions in the labeling. [2][3]
A risk notification is not a treatment choice
The device supports decisions about further referral or diagnostic follow-up. Its documentation says results should not direct therapy for atrial fibrillation, including anticoagulation. The clearance therefore supports a bounded clinical use of one AI device, rather than approval of Tempus’s entire platform or proof of improved patient outcomes. [3]
Sources
- About us
Tempus AI · retrieved Oct 23, 2026
- 510(k) Premarket Notification
FDA · Jun 21, 2024
- Tempus ECG-AF: 510(k) clearance letter and indications for use
FDA · Jun 21, 2024