Precision medicine company Tempus AI Inc (NASDAQ: TEM) announced on Wednesday that it has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AI-based Tempus ECG-AF device, which identifies patients at increased risk of atrial fibrillation/flutter (AF). This clearance is the first for AF in the 'cardiovascular machine learning-based notification software' category, enabling physicians to incorporate this algorithm into patient care.

AF, a leading cause of stroke, affects millions and is challenging to diagnose. Tempus' AI-driven clinical solutions aim to facilitate early identification of cardiovascular diseases. ECG-AF, the first in a suite of diagnostics, analyzes 12-lead ECG recordings to detect AF signs within the next 12 months in patients aged 65 and older without a known history of AF.

The device is designed to be used alongside other diagnostic information, including original ECG recordings, tests, and the patient's clinical history. It is not meant to provide a comprehensive risk assessment or serve as the sole basis for AF diagnosis or treatment.

Tempus leverages AI and one of the world's largest libraries of multimodal data to deliver personalised patient care and advance therapeutic discovery and development.