SoundBite Receives FDA 510(k) Clearance of the SoundBite Crossing System – Peripheral
MONTREAL January 21, 2020 – SoundBite Medical Solutions Inc. (SBMS) today announces it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SoundBite™ Crossing System, a unique active wire technology for use in the treatment of peripheral chronic total occlusions (CTOs).
“Through our collaborative approach with the FDA, we met the regulatory requirements and transformed a novel technology into a commercial product,” said Marc-André Côté, Director, Regulatory Affairs of SoundBite.
FDA 510(k) clearance indicates that the product complies with the requirements of 21 CFR 807 Subpart E and is authorized to be distributed and commercialized in the USA market.
“This significant milestone is very gratifying for all SoundBite employees who deployed an incredible amount of dedication and effort to make it happen. This also allows us to bring this innovative treatment solution to clinicians and their patients suffering from difficult-to-treat calcific PAD (Peripheral Artery Disease) in the US,” said Francis Bellido, CEO of SoundBite.
About SoundBite Medical Solutions Inc.
SoundBite Medical Solutions Inc. is developing proprietary shock wave technology to address significant unmet clinical needs in interventional vascular treatment. Through an elegant combination of hardware and software, it can, in a very controllable manner, deliver high amplitude shock wave pulses through guidewires and other interventional tools, to specifically attack highly calcified and fibrotic tissue in the vascular system, while leaving healthy, elastic arterial walls unharmed.
For information on SoundBite Medical Solutions, please contact Mandy Di Lazzaro, Director, Human Resources & Communications (mandy.dilazzaro@soundbitemedical.com) or Francis Bellido, CEO (francis.bellido@soundbitemedical.com), SoundBite Medical Solutions, 2300 Alfred Nobel, Technoparc St-Laurent, Montreal Québec H4S 2A4
For additional information visit www.soundbitemedical.com
