Tempus AI Enhances AI-Driven Diagnostics With Multiple FDA Approvals

In the first nine months of 2025, Tempus AI Inc. TEM achieved several key regulatory milestones that strengthened its position in AI-driven diagnostics. In September 2025, the company received FDA 510(k) clearance for its RNA-based Tempus xR IVD device, designed to aid drug development through advanced RNA sequencing. 

The Tempus xR IVD assay is a qualitative next generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for detection of rearrangements in two genes, using RNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens from patients with solid malignant neoplasms. 

In September, it also received FDA 510(k) nod for its updated Tempus Pixel, an AI-powered cardiac imaging platform. The update enables the generation of T1 and T2 inline maps, expanding the tool’s capabilities for cardiac MR image analysis. The new T1 and T2 maps provide precise numerical values to cardiac tissue characteristics, helping detect fibrosis, inflammation, or edema, even when MRI scanners lack this native functionality. This supports more precise and personalized cardiac care.

Additionally, in July 2025, Tempus received FDA 510(k) approval for Tempus ECG-Low EF (ejection fraction), an AI software that helps identify patients who may have a low left ventricular ejection fraction (LVEF ≤ 40%). This marks Tempus’ second FDA-cleared ECG-AI device, following ECG-AF, and expands its cardiovascular diagnostics suite. Tempus ECG-Low EF aims to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%). 

Peer Update

In September 2025, GE HealthCare GEHC received 510(k) clearance from the FDA for its Revolution Vibe CT system. The system delivers full-heart clarity in a single beat, even without ECG trace, to help empower fast, confident cardiac diagnoses. Its AI-powered workflow can also help cut exam time by 50% and double cardiac CT angiography (CCTA) capacity, helping providers meet rising demand for non-invasive cardiac imaging. 

In September, Guardant Health GH also received FDA approval for its Guardant360 CDx as a companion diagnostic to identify advanced breast cancer patients with ESR1 mutations who may benefit from Eli Lilly and Company’s Inluriyo (imlunestrant). This marks the second FDA-approved indication for Guardant360 CDx as a companion diagnostic in breast cancer treatment 

TEM Stock Outperforms Industry & Benchmark

In the past year, Tempus AI shares have rallied 105.8%, outperforming the industry’s 28.4% growth and the S&P 500 composite’s 18.8% improvement.

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Expensive Valuation

TEM currently trades at a forward 12-month Price-to-Sales (P/S) of 10.26X compared with the industry average of 5.87X.

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TEM Stock Estimate Trend

In the past 30 days, Tempus AI's loss per share estimate for 2025 has remained unchanged. 

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TEM stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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