SILICON VALLEY, CA, UNITED STATES, August 10, 2026 /EINPresswire.com/ — Silicon Valley medical technology company Vita Imaging today announced it has earned ISO 13485 certification from the British Standards Institution (BSI), achieving one of the medical technology industry’s most significant commercialization milestones and advancing its breakthrough, noninvasive skin cancer detection technology, AURA™, toward regulatory approvals and future market launch.
Awarded by one of the world’s leading standards and certification organizations, ISO 13485 certification validates Vita Imaging’s quality management system. The certification establishes that the company has met the rigorous processes required to design, develop and manufacture medical technology that meets internationally recognized quality standards. This achievement provides a foundation for regulatory approvals, commercial manufacturing, strategic partnerships and future global expansion for the company.
Vita Imaging’s breakthrough technology, AURA, is a noninvasive imaging platform designed to help physicians evaluate suspicious skin lesions in under 1.5 seconds using proprietary Raman spectroscopy technology. By providing clinicians with additional objective information during patient examinations, AURA has the potential to improve diagnostic confidence while supporting more informed biopsies and enhancing the overall patient experience.
“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, a globally recognized Notified Body under the European Union Medical Device Regulation (EU MDR), will serve as Vita Imaging’s regulatory partner as the company pursues CE Mark certification for AURA in Europe. With ISO 13485 certification now complete, Vita Imaging will continue advancing regulatory approvals while preparing for commercial manufacturing and market introduction.
This milestone 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. By delivering rapid, noninvasive evaluations at the point of care, Vita Imaging believes AURA has the potential to help physicians make more confident clinical decisions while improving patient outcomes through earlier detection.
For more information, please visit Vita-Imaging.com.
About Vita Imaging
Vita Imaging is a Silicon Valley medical technology company dedicated to the early detection of precancerous and malignant tumors. Its flagship technology, AURA™, is a patented, noninvasive device that helps physicians evaluate suspicious skin lesions in real time by providing objective diagnostic information during patient examinations. Backed by more than 20 years of research and development, Vita Imaging is committed to advancing technologies that enhance early detection and improve patient outcomes. To learn more, visit Vita-Imaging.com.
Karla Nafarrate
InnoVision Marketing Group
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