Tempus One

What can a provider ask it?

According to the vendor's page, it summarizes patient history, treatment journey and biomarker status, filters patients by alteration, gene or diagnosis, and adds or cancels tests such as xG, xG+, HRD and IHC. It also searches clinical trials by enrollment criteria, looks up history from the clinic's own notes and connects the user to a Tempus representative.

Two functions are described as available only in the EHR: real-time transcription with notes saved to the chart, and help preparing prior authorizations and next steps. The EHR route runs through a "Request EHR access" form, and no EHR vendor is named. A separate assistant, Tempus One for Researchers, sits in Lens and offers cohort building, exploration of unstructured data with source excerpts and generative summaries.

The homepage chatbot carries a warning not to share PHI and that it "may make errors". HIPAA, SOC 2, HITRUST, CLIA and CAP status for Tempus One are not stated.

Which FDA clearances belong to the Tempus name?

All of them are for other products. The 510(k) records for Tempus AI, Inc. are Tempus ECG-AF (K233549, June 21, 2024), Tempus ECG-Low EF (K250119, July 15, 2025), xR IVD (K241868, September 19, 2025), Tempus ECG-PH (K253699, August 21, 2026) and Tempus ECG-MR (K254297, September 25, 2026). Tempus Pixel, a radiology product (K252539, September 3, 2025), was cleared under the applicant name Arterys, Inc., now also in Chicago.

The oncology page separately advertises an "FDA-approved 648-gene solid tumor + normal DNA seq panel". The panel sits on a different regulatory path and appears on none of the 510(k) records. Whether Tempus One's generative features are positioned as non-device decision support is not stated.

What backs the assistant?

A PubMed search for "Tempus One" returns 437 hits, all unrelated trial and oncology papers that match the word "tempus". The praise on the One page is chosen by the vendor, from University of Florida Cancer Center, UC San Diego Health and The Oncology Institute. Thomas George, MD, of Florida says that asking Tempus One a spoken question about the status of a test is "super intuitive and easy to use".

Is there a price or an EHR list?

Neither. The page offers "Request a demo" and "Request EHR access" forms, and whether Tempus One is bundled with Tempus testing is not stated.

The verdict

Oncologists who already order Tempus assays are the users the order-status and add-on features address. FDA clearances under the Tempus name cover ECG, pathology and radiology products. Tempus One has none.