Tempus AI has received the US Food and Drug Administration (FDA) 510(k) approval for its AI-powered diagnostic tool that helps identify patients who are at risk of atrial fibrillation (AF).
The AI-powered algorithm, Tempus ECG-AF, is designed to analyse recordings of 12-lead electrocardiogram (ECG) devices.
Based on ECG recordings, the tool detects signs associated with patients who are at risk of experiencing AF in the coming 12 months.
Tempus ECG-AF is intended for use on resting 12-lead ECG recordings, collected at a healthcare facility, from patients aged 65 years and above, with no known history of AF.
It is the first FDA approval for an AF indication in the cardiovascular machine learning-based notification software category, said the health technology company.
Tempus Cardiology senior vice president Brandon Fornwalt said: “We believe that there are too many patients who die from AF-related causes unnecessarily due to underdiagnosis or undertreatment.
“The clearance of Tempus ECG-AF allows us to better support clinicians in potentially finding patients much earlier when treatments can be more effective.”
According to Tempus, AF is a common cause of stroke that affects millions of people and can be challenging to diagnose.
Tempus ECG-AF offers physicians an AI-based clinical solution that supports the potential for earlier identification of cardiovascular disease and conditions.
It is the company’s first next-generation diagnostic suite to identify patients at risk for a variety of cardiovascular conditions, said Tempus.
Tempus ECG-AF results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings, along with the patient’s symptoms and history.
The diagnostic solution is not intended to depict a person’s overall risk of AF and is not advised to be considered as the sole basis for diagnosis of AF.
Furthermore, its results are not recommended to be used as the basis for AF treatment and are not intended to rule out AF follow-up, said the company.
