Tempus receives u.s. fda 510(k) clearance for tempus ecg-af, an ai-based algorithm that identifies patients at increased risk of afib

Chicago--(business wire)--tempus ai, inc. (nasdaq: tem), a leader in artificial intelligence and precision medicine, today announced it has received 510(k) clearance from the u.s. food and drug administration (fda) for its tempus ecg-af device that uses ai to help identify patients who may be at increased risk of atrial fibrillation/flutter (af). this is the first fda clearance for an af indication in the category known as “cardiovascular machine learning-based notification software” and paves.
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