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Tempus AI Gains FDA Nod Amid Booming AI ECG Market Momentum
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Key Takeaways
TEM receives FDA 510(k) clearance for its ECG-Low EF AI software for detecting low ejection fraction.
TEM's AI tool analyzes 12-lead ECGs from patients aged 40+ at risk of heart failure in clinical settings.
TEM's ECG-Low EF is its second FDA-cleared AI ECG device amid at rapid market growth in the cardiology space.
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 - Free Report) 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 - Free Report) 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 - Free Report) 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.
Image Source: Zacks Investment Research
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.
Image Source: Zacks Investment Research
TEM Stock Estimate Trend
Earnings estimates for Tempus AI in 2025 and 2026 have remained unchanged in the past 60 days.
Image: Bigstock
Tempus AI Gains FDA Nod Amid Booming AI ECG Market Momentum
Key Takeaways
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 - Free Report) 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 - Free Report) 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 - Free Report) 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.
Image Source: Zacks Investment Research
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.
Image Source: Zacks Investment Research
TEM Stock Estimate Trend
Earnings estimates for Tempus AI in 2025 and 2026 have remained unchanged in the past 60 days.
Image Source: Zacks Investment Research
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.