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FDA clears Minn. startup's heart murmur detection device

The FDA gave Minnesota-based startup AUM Cardiovascular clearance to market its CADence System, a hand-held digital stethoscope that remotely connects to an artificial-intelligence system in a clinical setting to facilitate acoustic and electrical data analysis for the detection of heart murmurs in patients with chest pain. The company is also seeking clearance from the agency to market the device for coronary artery disease detection.

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