Tempus AI Gains FDA Nod Amid Booming AI ECG Market Momentum

The integration of artificial intelligence (AI) in the cardiovascular space, particularly in electrocardiography (ECG), is reshaping clinical workflows, enabling earlier disease detection and opening new market opportunities. Earlier this month, Tempus AI, Inc. TEM received 510(k) clearance from the FDA for its Tempus ECG-Low EF (ejection fraction) software, which uses AI to identify patients with a low left ventricular ejection fraction (LVEF).

ECG is one of the most widely used diagnostic tools in cardiovascular medicine. As cardiovascular diseases continue to rise globally with a rising ageing population, AI-powered ECG tools are emerging as a key component in modern healthcare systems. Per an analysis by Lucintel, the global AI ECG analysis system market is expected to witness a compound annual growth rate (CAGR) of 25.7% between 2024 and 2030.

Tempus ECG-Low EF software is designed to analyze resting, non-ambulatory 12-lead ECG recordings and detect indications for a low left ventricular ejection fraction (LVEF less than or equal to 40%). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients aged 40 years or older at risk of heart failure. Tempus ECG-Low EF is the second FDA-cleared ECG-AI device in Tempus AI’s growing suite of next-generation devices designed to identify patients at risk for a variety of cardiovascular conditions.

Recent Developments by TEM’s Peers in The Cardiology Field

In March 2025, GE Healthcare GEHC launched Revolution Vibe CT Scanner with Unlimited One-Beat Cardiac imaging. It delivers consistent, high-quality images for patients, even in challenging cases like atrial fibrillation and heavily calcified coronaries. Effortless Cardiac Workflow, leveraging AI, helps the system optimize scanning time and facilitate ease of usage for every user. Combined with the company’s impressive ECG-less Cardiac, TrueFidelity DL, SnapShot Freeze 2, Revolution Vibe enables fast, accurate diagnoses, a more comfortable patient experience and more efficient workflows.

iRhythm Technologies IRTC recently rolled out its AI powered Zio long-term continuous ECG monitoring (LTCM) system in Japan, following the Pharmaceuticals and Medical Devices Agency’s approval. It is a wearable, patch-based ECG device designed to continuously monitor heart rhythms for up to 14 days. The device is integrated with ZEUS, iRhythm’s deep-learning AI platform, which automatically analyzes ECG data for 13 arrhythmia types. In Japan, the system is the first AI-powered cardiac patch approved for arrhythmia detection. Additionally, Zio LTCM has gained CE Mark approval for launch across several European countries.

TEM Stock Outperforms Industry & Benchmark

In the past year, Tempus AI shares have surged 50.1%, outperforming the industry’s 13.4% growth and the S&P 500 composite’s 13.5% improvement.

Expensive Valuation

TEM currently trades at a forward 12-month Price-to-Sales (P/S) of 7.07X compared to the industry average of 5.82X.

TEM Stock Estimate Trend

Earnings estimates for Tempus AI in 2025 and 2026 have remained unchanged in the past 60 days.

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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