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BioSig PURE EP High Resolution Electrophysiology System Cleared in United States

BioSig Technologies, out of Los Angeles, California, won FDA clearance for its novel PURE EP, a system for gathering, analyzing, and manipulating electrocardiographic and intracardiac data during electrophysiology procedures. The company believes that its system can provide a more detailed and nuanced view of the heart during ablation procedures when treating atrial fibrillation and other heart rhythm disorders.

Ablation catheters can create a great deal of electrical background noise, throwing off the signal as viewed on an electrophysiology system. Sometimes the signal is so out of normal bounds that it can’t be displayed properly, forcing companies to implement front end filters to compensate for this signal drift.

The PURE EP system is able to reduce, and at times even eliminate, this noise. Moreover, instead of filtering the signal, BioSig’s technology allows the operator to pin the signal to the baseline while preventing the noise from corrupting the real-time data. According to Ken Londoner, Founder and Executive Chairman of BioSig, who we spoke with last year, PURE EP allows surgeons to detect signals as small as one microvolt in amplitude. This is done with a combination of novel hardware and software components.

Flashbacks: BioSig’s Pure EP System Detects Deadly Cardiac Arrhythmia Cells (Interview)…BioSig Technologies Announces FDA 510(k) Submission for PURE EP (A Follow-up Interview)…

Product page: PURE EP System…

Via: BioSig…

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