Boston Scientific (BSX) said Friday the US Food and Drug Administration approved the Farawave NAV ablation catheter for the treatment of paroxysmal atrial fibrillation.
The FDA also issued a 510(k) clearance for the company's Faraview software that magnetically tracks the Farawave catheter. The two technologies, in combination with the company's OPAL HD mapping system, will provide visualization for cardiac ablation procedures with its Farapulse pulsed field ablation system, Boston Scientific said.
The company plans to will launch technologies immediately in the US.
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