Article Image Placeholder
The AI algorithm for detecting coronary artery disease from standard 12-lead ECG receives FDA 510(k) clearance.
HeartSciences announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's AI algorithm for detecting coronary artery disease (CAD) from standard 12-lead ECG recordings.
The algorithm was validated in clinical studies involving over 50,000 patients, demonstrating high sensitivity and specificity for identifying patients with significant coronary artery disease.