Lakeway, TX – Vigilant Biosciences is pleased to announce the successful approval of its BeVigilant™ OraFusion™ System under the In Vitro Diagnostic Regulation (IVDR), marking a significant milestone for international expansion. Additionally, Vigilant received approval in key markets, including Turkey, Malaysia, and Thailand. This strategic move opens the doors to a combined market size of approximately $15 billion, positioning Vigilant to significantly enhance its footprint in the rapidly growing diagnostics industry.
The BeVigilant OraFusion System is a cutting-edge diagnostic tool that provides rapid and accurate results, empowering healthcare providers to make informed decisions and improve patient outcomes. With its IVDR approval, the system is now set to be introduced in multiple key international markets, where demand for innovative diagnostic solutions continues to rise.
“We are thrilled to receive IVDR approval for the OraFusion,” said Bill Brodie, CEO of Vigilant Biosciences. “This expansion aligns with our mission to save lives while delivering advanced diagnostic solutions globally, ultimately improving healthcare accessibility and quality for patients in these regions. More than 700,000 new oral cancer cases are diagnosed each year, and it is one of the few cancers that is growing rapidly throughout the world, including an increase in death rates in many markets.”
The expansion into international markets comes at a time when healthcare systems are increasingly focused on enhancing diagnostic capabilities. The BeVigilant OraFusion System is designed to meet the needs of diverse populations, providing reliable testing solutions that can be adapted to various healthcare settings.
Vigilant is committed to supporting healthcare professionals with the tools they need to deliver exceptional patient care. The company’s expansion into these markets will be accompanied by comprehensive training and support for local healthcare providers, ensuring the effective implementation of the OraFusion system.
As Vigilant prepares for its launch, the company looks forward to establishing partnerships with local distributors and healthcare institutions. This collaboration will facilitate a seamless introduction of the OraFusion system and promote its benefits to both healthcare professionals and patients.
For more information about BeVigilant and its innovative OraFusion system, please visit www.vigilantbiosciences.com.
Vigilant Biosciences is a leading provider of advanced diagnostic solutions committed to improving patient care through innovative technology. With a focus on quality, reliability, and accessibility, Vigilant is dedicated to supporting healthcare professionals worldwide.
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