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.