SILICON VALLEY, Calif. — Vita Imaging, a Silicon Valley medical technology company, announced it has earned ISO 13485 certification from the British Standards Institution (BSI) for its noninvasive skin cancer detection technology, AURA™.
The ISO 13485 certification validates Vita Imaging's quality management system and establishes that the company has met the rigorous processes required to design, develop and manufacture medical technology. Vita Imaging receiving the ISO 13485 certification provides a foundation for commercial manufacturing, strategic partnerships, regulatory approvals and future global expansion for the company.
AURA is a noninvasive imaging platform that is designed to help physicians evaluate suspicious skin lesions in less than 1.5 seconds, using proprietary Raman spectroscopy technology. AURA has the potential to improve diagnostic confidence while supporting more informed biopsies and enhancing the overall patient experience because it provides clinicians with additional objective information during patient examinations.
“This certification represents years of work building not only innovative technology, but the quality systems required to bring that innovation to the physicians and patients who need it most," said Thinh Tran, CEO of Vita Imaging. "For us, this milestone is about much more than earning a certification. It validates that we've built the foundation to responsibly commercialize AURA and move one step closer to giving clinicians a faster, noninvasive tool that has the potential to improve skin cancer detection and ultimately change lives."
The certification also marks an important step in Vita Imaging's broader regulatory strategy. BSI is a globally recognized Notified Body under the European Union Medical Device Regulation (EU MDR) and will serve as Vita Imaging's regulatory partner while the company pursues CE Mark certification for AURA in Europe. With ISO 13485 certification now complete, Vita Imaging will continue to advance regulatory approvals while it prepares for commercial manufacturing and market introduction.
The certification builds upon more than two decades of research and development behind Vita Imaging's proprietary technology and reflects the company's continued progress toward transforming how skin cancer is detected. Vita Imaging believes AURA has the potential to help physicians make more confident clinical decisions while improving patient outcomes through earlier detection by delivering rapid, noninvasive evaluations at the point of care.
