Tempus Scores FDA Clearance for AI ECG Software to Flag Low LVEF

Tempus AI announced the FDA 510(k) clearance of its Tempus ECG‑Low EF software this week.

This marks the company’s second AI-powered ECG tool cleared by the FDA, following its ECG‑AF application that identifies atrial fibrillation risk.

The Tempus ECG‑Low EF software is designed to analyze resting, non-ambulatory 12‑lead ECG recordings to flag patients aged 40 and older who may have a left ventricular ejection fraction (LVEF) of 40% or less — a critical threshold associated with heart failure, cardiomyopathy and post-heart attack damage.

Its intended use covers a broad range of patients at risk, including those with atrial fibrillation, hypertension, diabetes and ischemic heart disease.

“With Tempus ECG-Low EF, we’re adding another powerful tool to the hands of clinicians to help them identify patients at risk for serious cardiovascular conditions much earlier in their care journey,” said Brandon Fornwalt, MD, PhD, senior vice president of Cardiology at Tempus.

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While ECG‑Low EF provides a binary output to aid interpretation, Tempus emphasizes that it is not a stand-alone diagnostic tool. Healthcare providers are advised to interpret results within the context of additional clinical data, such as imaging, lab results, symptoms and medical history.

According to Dr. Fornwalt, “Detection of LVEF is essential for undiagnosed patients, and this technology enables us to deliver that capability at scale to transform patient care.”

In June 2024, Tempus received FDA 510(k) clearance for ECG‑AF, its AI‑based algorithm designed to identify patients aged 65 and older who may have undiagnosed atrial fibrillation or flutter within the next 12 months. This marked the first FDA clearance for a machine learning-based notification device specifically targeting atrial fibrillation risk.

Tempus plans to integrate ECG‑Low EF into existing clinical workflows, enabling scalable deployment across hospitals and outpatient settings.

The company said it is focusing on partnerships with electronic health record (EHR) providers to ensure seamless implementation. This continued expansion reflects Tempus’ mission — using AI to surface critical insights from routine diagnostic data and improve patient outcomes.

Related: How the HeartBeam 12-Lead ECG Stacks Up: New Data Shows Clinical Promise

The global ECG market — covering devices, leads, monitors and analysis platforms — was valued at approximately $12 billion in 2024, and is projected to reach $30.9 billion by 2034, growing at a compound annual growth rate (CAGR) of around 9.9%.

Within this broader field, the AI ECG or automated ECG analysis market has emerged as a rapidly growing segment. In 2024, AI ECG toolings (software and platforms that apply machine learning to ECG signals) were valued at nearly $1 billion, and they are projected to grow to a value of about $2.85 billion by 2033 with a CAGR of approximately 13.7%.

Alternative estimates suggest even faster growth: the specialized AI ECG analysis system sector could reach $5.4 billion by 2033 (CAGR ~22%), while AI platforms broadly focused on cardiology may grow to $4.8 billion to 40 billion across segments by the early 2030s.

While Tempus’ FDA-cleared tools target atrial fibrillation risk and reduced ejection fraction, its competition includes companies offering AI-enabled ECG with a reduced leadset and consumer-facing onboarding (AliveCor), multipurpose stethoscope-based screening (Eko) and targeted low-EF analysis (Anumana).

Meanwhile, upcoming entrants like EchoNext and HeartSciences are expanding AI ECG’s capabilities into structural heart disease and valvular screening.

Santa Clara, California-based HeartBeam is developing a compact handheld ECG device for at-home heart monitoring, which demonstrated 93.4% diagnostic agreement with standard 12-lead ECGs in a pivotal trial. The company submitted it for FDA clearance in January and has launched an Early Access Program to prepare for US rollout.