Kane Biotech Announces FDA 510(k) Clearance for revyve® Antimicrobial Skin and Wound Cleanser

Core Insights - Kane Biotech Inc. has achieved significant regulatory milestones that enhance its wound care platform and commitment to high-quality medical device development [1] Regulatory Approvals - The company has received FDA 510(k) clearance for its revyve Antimicrobial Skin and Wound Cleanser, which is designed for the cleansing and moistening of various acute and chronic dermal lesions, including pressure ulcers and diabetic foot ulcers [2] - This clearance validates Kane's expanded revyve product line, which targets wound bacteria and biofilms, key factors in delayed healing and antibiotic resistance [2] Certification Expansion - Kane has expanded its ISO 13485:2016 certification under the Medical Device Single Audit Program (MDSAP) to include distribution and wound cleansers, building on existing certifications for nonsterile antimicrobial wound dressings [3] - This expansion aligns with the FDA's new Quality Management System Regulation (QMSR) effective February 2026, harmonizing U.S. requirements with ISO 13485 [3] Commitment to Quality - The expanded certification supports Kane's ability to pursue regulatory approvals across multiple jurisdictions and demonstrates its investment in quality systems and operational readiness [4] - The Chief Quality Officer emphasized that compliance with ISO 13485 and MDSAP enhances trust among healthcare providers and patients, ensuring alignment with evolving regulatory expectations [5]