Chicago-based Tempus AI has gained clearance from the U.S. Meals and Drug Administration (FDA) for a brand new synthetic intelligence (AI) algorithm that identifies sufferers who could face a heightened threat of experiencing atrial fibrillation (AFib).
The Tempus ECG-AF algorithm evaluates 12-lead electrocardiogram (ECG) outcomes, alerting customers when the affected person might be susceptible to experiencing AFib throughout the subsequent 12 months. The corporate emphasised that the newly accepted AI mannequin ought to be used at the side of different knowledge, together with the affected person’s authentic 12-lead ECG outcomes. It was particularly designed for sufferers 65 years outdated and older with no prior historical past of AFib.
“We consider that there are too many sufferers who die from AFib-related causes unnecessarily attributable to underdiagnosis or undertreatment,” Brandon Fornwalt, MD, PhD, senior vice chairman of cardiology at Tempus, stated in a ready assertion asserting the FDA clearance. “The clearance of Tempus ECG-AF permits us to higher assist clinicians in probably discovering sufferers a lot earlier, when therapies could be more practical.”
