The non-invasive medical device system assists in the diagnosis of significant coronary artery disease. Credit: CorVista Health / Business Wire.

The US Food and Drug Administration (FDA) has approved CorVista Health’s non-invasive medical device system with a CAD [coronary artery disease] Add-On option for detecting the presence of cardiac disease.

Designed to assist in the diagnosis of significant CAD, the new CorVista System features hardware and software components.

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Working together, these components enable a physician to assess the patient at the point of care for cardiac disease, leveraging a static machine-learned detection algorithm.

The CAD Add-On is claimed to be the first in the company’s anticipated suite of cardiac detection algorithms to secure market approval.

The device will assist in analysing sensor-acquired physiological signals from patients presenting with cardiovascular symptoms such as fatigue, chest pain and dyspnea, thereby aiding in the assessment of the likelihood of significant CAD.

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Healthcare providers can use the analysis for interpretation, in conjunction with their clinical judgement and the signs, symptoms and clinical history of the patient, as a diagnostic tool.

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The approval was granted after the evaluation of a blinded clinical validation dataset from the IDENTIFY study.

This dataset demonstrated the ability to detect significant CAD with 88% sensitivity and 51% specificity.

CorVista Health president and CEO Don Crawford said: “Our point-of-care, non-invasive solution rules out significant CAD with a negative predictive value of 99%. Furthermore, it requires no fasting, radiation, or significant capital investment.

“The ability to obtain a result within minutes will be a game changer in aiding physicians to detect the potential presence of cardiac disease.”