Rijuven has secured 510(k) clearance from the FDA for prescription use of its CardioSleeve system, which attaches to a stethoscope to allow clinicians to use mobile devices to capture a patient's heart rhythms and ECG data for evaluation. The technology also comes with clinical decision support software to help clinicians examine heart murmurs.
Rijuven's mobile-based stethoscope accessory device wins FDA nod
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