Wednesday, 22 November 2017

FDA clears AUM’s diagnostic cardiovascular device

10 August 2017 | News

The device employs an algorithm and features specific software that crunches the acoustic data presented in the report to enable a physician to analyse the patient's cardiovascular health.

Courtesy- Max Pixel

Courtesy- Max Pixel

The US Food and Drug Administration (FDA) has cleared AUM Cardiovascular’s acoustic and electrocardiogram (ECG) device called CADence to aid detection of physiological and pathological heart murmurs.

CADence is a non-invasive, radiation-free handheld and reusable device designed to record sounds emitted by a patient’s heart. It has been used in a total of 1,807 patients to date.

The device employs an algorithm and features specific software that crunches the acoustic data presented in the report to enable a physician to analyse the patient's cardiovascular health.

The firm is currently working towards obtaining clearance from the FDA to commercialise CADence for CAD detection, with plans to launch additional algorithms that can crunch the acoustic data to detect stenosis, which is characterised by clogged arteries with plaque.

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