Demonstrating a commitment to quality and surgical excellence
BOSTON, MA – February 11th, 2025 – InnoVoyce, a leading medical technology company, proudly announces its ISO 13485:2016 certification, underscoring its dedication to excellence in the design, manufacturing, installation, and servicing of lasers and fiber devices. Alongside this milestone, the company is thrilled to share that its FDA-cleared VYLO™ 455nm Blue Light Laser System is now available nationwide, offering healthcare professionals an advanced tool for treating laryngeal disorders and a wide range of surgical applications.
“InnoVoyce is driven by the principles of advancing healthcare through innovative, patient-focused technologies,” said Michael Davin, CEO of InnoVoyce. “Achieving ISO 13485 certification validates our commitment to maintaining the highest quality standards, while the nationwide availability of our VYLO Laser System marks a significant step in making best-in-class surgical solutions accessible to providers and patients across the country.”
ISO 13485 is a globally recognized benchmark for quality management systems specific to medical devices, ensuring safety, reliability, and performance. InnoVoyce successfully completed rigorous audits by TÜV USA, confirming its quality management system complies with all requirements of the ISO 13485:2016 design and manufacturing standards.
“We are dedicated to quality, compliance, and the safety of our users and patients,” says Dominique Winslow, Director of Quality at InnoVoyce. “To demonstrate this commitment, we have built an ISO 13485 certified Quality Management System for our InnoVoyce VYLO laser and fibers.”
The VYLO Laser System, the first and only 455nm blue light laser with up to 30 watts of power and four emission modes, is designed to meet the diverse needs of soft tissue surgery. Its optimized wavelength and advanced engineering enable accurate tissue targeting while reducing impact on surrounding areas. Suitable for a wide range of applications, the VYLO system is particularly well-suited for procedures in ENT, gynecology, general surgery, urology, and other specialties, making it a valuable tool in both clinical and surgical settings.
Now available nationwide, the VYLO Laser System provides healthcare providers across the country with access to its advanced features. With its thoughtful design and engineering, the system is built to improve procedural efficiency and minimize impact on surrounding tissues. Supported by InnoVoyce’s training and support programs, the VYLO Laser System is designed to help surgeons perform procedures effectively and deliver improved patient care.
To learn more about InnoVoyce and the VYLO Laser System, visit www.innovoyce.com
About InnoVoyce
InnoVoyce is at the forefront of innovation, developing cutting-edge, solid-state laser technologies for clinical and surgical settings. As a leading provider, we exceed expectations through our clinically validated, high-quality solutions and unparalleled customer service. Driven by a mission to empower healthcare professionals, InnoVoyce is committed to delivering advanced technology supported by robust scientific evidence and endorsements from renowned institutions and surgeons. Our collaboration with top-tier medical and scientific experts ensures our products align with technological excellence, making a positive impact on laser science worldwide.
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