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Medical Devices / Submissions and Approvals

FDA Grants 510(k) Clearance to BioSig’s Cardiac Signal Device

Aug. 15, 2018

BioSig Technology’s Pure EP System, a medical device that measures, records and displays high fidelity cardiac signals, received 510(k) clearance from the FDA.

The device is intended for use in an electrophysiology (EP) laboratory to provide visualization tools that can help to analyze a patient’s intracardiac and electrocardiographic signals during EP procedures.

The computerized system is non-invasive and can potentially increase the diagnostic value of the signals, improving EP study accuracy and efficiency. It is indicated for use by licensed healthcare practitioners who interpret the data.

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