InnoVoyce Earns ISO 13485 Certification and Launches VYLO™ Blue Light Laser for Healthcare Professionals

InnoVoyce Achieves ISO 13485 Certification and Nationwide Availability of VYLO™ Blue Light Laser System

InnoVoyce, a leader in medical technology, has recently announced a significant accomplishment: the attainment of ISO 13485:2016 certification. This achievement highlights the company's relentless commitment to excellence in the design, manufacturing, installation, and servicing of medical lasers and fiber devices.

The ISO 13485 certification represents a globally recognized benchmark for quality management systems in the medical device industry. By successfully completing rigorous audits conducted by TÜV USA, InnoVoyce demonstrated that its quality management system meets all stringent requirements set forth by the ISO standards.

Michael Davin, the CEO of InnoVoyce, expressed the company's dedication to healthcare innovation by stating, "Achieving ISO 13485 certification validates our commitment to maintaining the highest quality standards. The nationwide availability of our VYLO Laser System marks a significant step in making exceptional surgical solutions accessible to providers and patients across the country."

Accompanying this announcement is the national launch of InnoVoyce's FDA-cleared VYLO™ 455nm Blue Light Laser System. This advanced tool is specifically engineered to assist healthcare professionals in treating laryngeal disorders and is versatile enough for a variety of surgical applications. The VYLO Laser System distinguishes itself as the first and only laser system capable of emitting 455nm blue light with up to 30 watts of power and four emission modes.

InnoVoyce's VYLO System is designed to cater to diverse needs in soft tissue surgery. With its optimized wavelength and state-of-the-art engineering, the device allows for precise targeting of tissue while minimizing trauma to surrounding areas. It is ideal for a broad spectrum of medical fields, including ENT, gynecology, general surgery, urology, and more.

The company is convinced that the VYLO Laser System will enhance procedural efficiency in various surgical settings. Its thoughtful design not only prioritizes the well-being of patients but also comes backed by comprehensive training and support programs offered by InnoVoyce. These programs aim to equip healthcare providers with the knowledge and skills necessary for effective use of the system, ultimately improving patient care outcomes.

Dominique Winslow, the Director of Quality at InnoVoyce, reiterated the company's commitment to user and patient safety by stating, "Our ISO 13485 certified Quality Management System serves as a foundation for ensuring that our products, such as the VYLO Laser and fibers, meet the highest standards in quality and compliance."

Healthcare providers across the nation can now access the cutting-edge VYLO Laser System, marking a pivotal moment in surgical technology. InnoVoyce aims to make a notable impact on laser science and healthcare innovation, and its collaboration with leading medical experts positions the company at the forefront of the industry.

To learn more about InnoVoyce and discover the VYLO Laser System's capabilities, visit their official website at www.innovoyce.com.

In conclusion, InnoVoyce's dedication to advancing healthcare through innovative technologies is exemplified not only by their ISO certification but also by the launch of the VYLO Laser System, which is set to elevate the standards of surgical procedures across the country.