13 April 2023 - Designation represents progress for patients with suspected coronary microvascular dysfunction as the FDA recognises disease’s debilitating impacts and the lack of effective non-invasive options for efficient diagnosis.
Genetesis today announced that the US FDA has granted the company breakthrough device designation for its flagship imaging solution, CardioFlux MCG, to identify myocardial ischaemia in patients who may be suffering from coronary microvascular disease.