The Tempus ECG-AF results are recommended to be used alongside other diagnostic information. Credit: witsarut sakorn / Shutterstock.

The US Food and Drug Administration (FDA) has issued 510(k) clearance to Tempus AI’s ECG-AF device.

Using AI, the Tempus ECG-AF device can identify patients at an increased risk of atrial fibrillation (AF) or flutter.

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Tempus said that this is the first clearance by the FDA for an AF indication in the ‘cardiovascular machine learning-based notification software’ category.

The Tempus ECG-AF algorithm is designed to analyse 12-lead electrocardiogram (ECG) recordings to detect signs that could indicate a patient’s likelihood of experiencing AF within the next 12 months.

Intended for use on resting 12-lead ECGs from patients aged 65 and older without a known history of AF, the device is a step towards proactive cardiovascular healthcare.

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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.

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“The clearance of Tempus ECG-AF allows us to better support clinicians in potentially finding patients much earlier when treatments can be more effective.”

Clinicians are advised to use the Tempus ECG-AF results alongside other diagnostic information, the company said.

This includes the patient’s original ECG recordings, additional tests, symptoms, and clinical history.

The device’s role is to supplement existing diagnostic processes, not to replace them or act as the sole basis for diagnosing AF.

Earlier this month, Tempus launched new testing solutions to help identify patients with HER2 or FOLR1-expressing tumours.

The new HER2 and FOLR1 testing solutions are designed to help identify patients eligible for targeted therapies such as antibody-drug conjugates (ADCs).