This section highlights FDA-related milestones and regulatory updates for drugs developed by Tempus AI (TEM).
Over the past two years, Tempus AI has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Tempus and xT. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Tempus ECG-MR FDA Regulatory Events
Tempus ECG-MR is a drug developed by Tempus AI for the following indication: to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Tempus ECG-MR
- Announced Date:
- September 28, 2026
- Indication:
- to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR).
Announcement
Tempus AI, Inc announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-MR, an AI product that analyzes standard 12-lead resting electrocardiograms (ECGs) to detect signs associated with undiagnosed moderate or severe mitral regurgitation (MR).
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XT CDx FDA Regulatory Events
XT CDx is a drug developed by Tempus AI for the following indication: For colorectal cancer patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- xT CDx
- Announced Date:
- January 15, 2025
- Indication:
- For colorectal cancer patients
Announcement
Tempus AI, Inc announced the national launch of the company's FDA-approved, NGS-based in vitro diagnostic device, xT CDx. Beginning today, xT CDx is now available for all ordering clinicians nationwide.
AI Summary
Tempus AI, Inc has launched its FDA-approved, next-generation sequencing in vitro diagnostic device, xT CDx, now available nationwide for all ordering clinicians. This new test uses one of the largest reported gene panels, analyzing 648 genes to provide comprehensive tumor profiling, including microsatellite instability status and essential companion diagnostic information for cancer treatment decisions.
Utilizing a normal-matched approach, xT CDx sequences both tumor and normal patient samples simultaneously to offer more accurate detection of cancer-driving genetic alterations. The test supports clinicians in making informed, precise treatment choices for patients with solid tumors. With its national launch, Tempus aims to broaden access to high-quality genomic insights and further advance precision medicine in everyday patient care.
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