Tempus receives FDA clearance for heart condition detection software

Tempus AI, Inc. (NASDAQ: TEM) received 510(k) clearance from the U.S. Food and Drug Administration for its Tempus ECG-Low EF software, which uses artificial intelligence to identify patients who may have a low left ventricular ejection fraction.

The software analyzes resting 12-lead ECG recordings to detect signs associated with having a low left ventricular ejection fraction of 40% or less. It is intended for use on clinical diagnostic ECG recordings from patients 40 years of age or older at risk of heart failure, including those with conditions such as atrial fibrillation, diabetes, hypertension, and ischemic heart disease.

Tempus ECG-Low EF represents the second FDA-cleared ECG-AI device in the company's cardiovascular portfolio, joining Tempus ECG-AF. The software provides a binary output for interpretation and is not intended as a stand-alone diagnostic tool.

Ejection fraction measures the percentage of blood the heart pumps out with each beat. A reduced left ventricular ejection fraction may indicate cardiovascular conditions including heart failure, cardiomyopathy, or damage from a prior heart attack.

The software cannot be used for patient monitoring or on ECGs with paced rhythms. Results must be interpreted alongside other diagnostic information, including the patient's original ECG recordings, symptoms, and clinical history. A positive result may suggest the need for further clinical evaluation to establish a diagnosis of low ejection fraction.

The information is based on a company press release statement.

You May Also Be Interested In

• Natera's Signatera wins Japan approval for colorectal cancer
• IMUNON's Phase 3 ovarian cancer trial cleared to continue by safety panel
• FDA conditionally approves QYLEKI as brand name for Quoin drug