“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.”
— Thinh Tran, CEO of Vita Imaging
SILICON VALLEY, CA, UNITED STATES, August 10, 2026 /EINPresswire.com/ — Vita Imaging, a Silicon Valley-based medical technology company, announced today that it has obtained ISO 13485 certification from the British Standards Institution (BSI). This marks one of the most important commercialization milestones in the medical technology industry for the company, advancing its innovative, noninvasive skin cancer detection system AURA™ toward regulatory approvals and eventual market introduction.
ISO 13485 certification, granted by a globally recognized standards and certification body, confirms that Vita Imaging’s quality management system meets the strict requirements for designing, developing, and manufacturing medical devices that adhere to internationally accepted quality standards. This accomplishment lays the groundwork for future regulatory clearances, commercial production, strategic alliances, and worldwide expansion.
Vita Imaging’s AURA platform is a noninvasive imaging system that enables physicians to assess suspicious skin lesions in under 1.5 seconds using proprietary Raman spectroscopy technology. By delivering additional objective data during patient exams, AURA may enhance diagnostic certainty, support more informed biopsy decisions, and improve the overall experience for patients.
“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 represents a key advancement in Vita Imaging’s broader regulatory plan. 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 seeks CE Mark certification for AURA in Europe. With ISO 13485 certification now secured, Vita Imaging will continue progressing through regulatory approvals while preparing for commercial manufacturing and market entry.
This achievement builds on more than two decades of research and development behind Vita Imaging’s proprietary technology and reflects the company’s ongoing progress toward changing how skin cancer is detected. By providing rapid, noninvasive evaluations at the point of care, Vita Imaging believes AURA could help physicians make more confident clinical decisions and improve 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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