HeartLung's AutoChamber gets FDA nod

AI developer HeartLung Technologies has received breakthrough medical device designation and marketing authorization from the U.S. Food and Drug Administration (FDA) for its Automated Cardiac Chambers Volumetry (AutoChamber) software.

AutoChamber reports the volume of cardiac chambers and left ventricular wall mass in noncontrast CT scans for coronary artery calcium (CAC) scoring and in lung scans for lung cancer screening. It also works on coronary CT angiography (CCTA) scans. By adding AutoChamber AI to CAC scans and analyzing both coronary artery plaque calcification and cardiac chamber volume, HeartLung plans to introduce AI-CAC and AI-CVD [cardiovascular disease] to advance preventive cardiology.

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