InnoVoyce Celebrates Significant Milestone
InnoVoyce, a leading player in the medical technology landscape, has reached an important benchmark with the achievement of its ISO 13485:2016 certification. This notable accomplishment highlights the company's unwavering commitment to excellence in the design, manufacture, installation, and servicing of laser systems and fiber devices.
Nationwide Launch of VYLO™ 455nm Blue Light Laser System
In conjunction with its newly attained certification, InnoVoyce is excited to announce that its FDA-cleared VYLO™ 455nm Blue Light Laser System is now available nationwide. This state-of-the-art technology serves as an advanced solution for healthcare professionals tackling laryngeal disorders and a variety of surgical tasks.
Commitment to Quality Standards
The ISO 13485 certification serves as a global standard for quality management systems tailored to the medical device sector, ensuring that products meet stringent safety, reliability, and performance criteria. InnoVoyce's successful navigation of tough audits administered by T\u00dcV USA validates its operational excellence and compliance with the ISO 13485:2016 standards.
Statements from Leadership
Michael Davin, CEO of InnoVoyce, emphasized the company’s commitment to advancing healthcare through innovative technologies. He stated, "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."
Enhancing Surgical Procedures
The VYLO Laser System, recognized as the first and only device of its kind utilizing a 455nm wavelength and featuring up to 30 watts of power along with four emission modes, is designed for a variety of soft tissue surgical applications. Its optimized wavelength and engineered precision allow for targeted tissue treatment, aiming to minimize impact on surrounding areas.
Versatile Applications Across Specialties
This cutting-edge technology is a valuable asset in several medical specialties, including ENT, gynecology, general surgery, and urology, providing a versatile tool in both clinical and surgical environments. The easy access to VYLO Laser System across the country ensures that healthcare providers can leverage its advanced features for effective patient care.
Investment in Training and Support
InnoVoyce is dedicated not only to product excellence but also to comprehensive support for healthcare providers. With strong training programs in place, the VYLO Laser System equips surgeons with the necessary resources to perform procedures effectively while enhancing patient care outcomes.
About InnoVoyce
InnoVoyce is at the helm of developing innovative solid-state laser technologies tailored for clinical use. As a key player in the industry, the company prides itself on delivering high-quality solutions backed by clinical validation and exceptional customer service. A collaborative approach with prominent medical and scientific experts ensures that InnoVoyce products align with technological advancements and continue to foster positive impacts on the field of laser science globally.
Media Contact Information:
For media inquiries, reach out to Sheree Titan-Ford from InnoVoyce at 508-308-7019.
Frequently Asked Questions
What is ISO 13485 certification?
ISO 13485 certification is an international standard that specifies requirements for a quality management system specific to medical devices, ensuring safety and quality throughout their lifecycle.
What is the VYLO 455nm Blue Light Laser System?
The VYLO 455nm Blue Light Laser System is a sophisticated medical device designed for soft tissue surgeries, offering various power settings and emission modes for precision treatment.
Which medical fields can use the VYLO Laser System?
This laser system is applicable in multiple specialties, including ENT, gynecology, general surgery, and urology, making it a versatile surgical tool.
How does InnoVoyce ensure product quality?
InnoVoyce ensures product quality through rigorous compliance with ISO 13485 standards, continuous quality checks, and audits by independent organizations.
What support does InnoVoyce offer to healthcare providers?
InnoVoyce provides extensive training and support programs to empower healthcare professionals in using the VYLO Laser System efficiently and safely.
