Tempus AI, Inc., a leader in artificial intelligence and precision medicine, 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 the way for physicians to use this innovative algorithm in the care of their patients.’
AF, a common cause of stroke, affects millions of people and can be challenging to diagnose. This clearance solidifies Tempus’ innovative approach to offering physicians AI-based clinical solutions that support the potential for earlier identification of cardiovascular disease and conditions. ECG-AF is the first of a suite of next generation diagnostics that Tempus has designed to identify patients at risk for a variety of cardiovascular conditions.
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“We believe that there are too many patients who die from AF-related causes unnecessarily due to underdiagnosis or undertreatment,” said Brandon Fornwalt, MD, PhD, Senior Vice President of Cardiology at Tempus. “The clearance of Tempus ECG-AF allows us to better support clinicians in potentially finding patients much earlier, when treatments can be more effective.”
The Tempus ECG-AF algorithm is intended for use to analyze recordings of 12-lead electrocardiogram (ECG) devices and detect signs associated with a patient experiencing AF within the next 12 months. It is for use on resting 12-lead ECG recordings collected at a healthcare facility from patients 65 years of age or older who do not have a known history of AF or other specified conditions. The device provides clinicians with results that should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history. Tempus ECG-AF does not describe a person’s overall risk of experiencing AF and should not serve as the sole basis for diagnosis of AF. Results should not be used as the basis for treatment of AF and are not intended to rule out AF follow-up.
Source: Businesswire
