SoundBite System Nabs 510(k) Clearance

January 22, 2020

SoundBite Medical Solutions was granted 510(k) clearance by the FDA for its  SoundBite Crossing System for use in the treatment of peripheral chronic total occlusions. 

The system delivers high amplitude pulses through guidewires and other interventional tools, to attack fibrotic tissue in the vascular system, while leaving healthy, elastic arterial walls unharmed. 

The Montreal-based company plans to launch the product in the U.S. market for treatment of “patients suffering from difficult-to-treat calcific peripheral artery disease,” said CEO Francis Bellido.

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