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 ImagingSILICON VALLEY, CA, UNITED STATES, August 10, 2026 /EINPresswire.com/ — Today, Vita Imaging, a Silicon Valley medtech firm, revealed that it has obtained ISO 13485 certification from the British Standards Institution (BSI), marking a major commercialization milestone in the medical technology sector and moving its noninvasive, cutting-edge skin cancer detection platform, AURA™, closer to regulatory clearances and eventual market entry.
Granted by a premier global standards and certification body, ISO 13485 certification confirms that Vita Imaging’s quality management system meets the stringent requirements necessary for designing, developing, and manufacturing medical devices that adhere to internationally accepted quality benchmarks. This accomplishment lays the groundwork for regulatory approvals, commercial production, strategic alliances, and future worldwide growth for the organization.
Vita Imaging’s innovative AURA system is a noninvasive imaging platform that enables clinicians to assess suspicious skin lesions in under 1.5 seconds using proprietary Raman spectroscopy technology. By delivering additional objective data during patient exams, AURA has the capacity to boost diagnostic certainty and facilitate more informed biopsy decisions while improving the overall patient journey.
“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 critical advancement in Vita Imaging’s broader regulatory roadmap. BSI, a globally recognized Notified Body under the European Union Medical Device Regulation (EU MDR), will act as Vita Imaging’s regulatory partner as the company pursues CE Mark certification for AURA in Europe. With ISO 13485 certification achieved, Vita Imaging will push forward with regulatory approvals while preparing for commercial manufacturing and market introduction.
This achievement builds on more than two decades of research and development behind Vita Imaging’s proprietary technology and underscores the company’s ongoing progress toward revolutionizing skin cancer detection. By offering rapid, noninvasive evaluations at the point of care, Vita Imaging believes AURA can help physicians make more confident clinical decisions and improve patient outcomes through earlier detection.
For additional details, please visit Vita-Imaging.com.
About Vita Imaging
Vita Imaging is a Silicon Valley medical technology company devoted to the early detection of precancerous and malignant tumors. Its lead product, AURA™, is a patented, noninvasive device that assists physicians in evaluating suspicious skin lesions in real time by providing objective diagnostic information during patient exams. Supported by over 20 years of research and development, Vita Imaging is dedicated to advancing technologies that improve early detection and enhance patient outcomes. To learn more, visit Vita-Imaging.com.
Karla Nafarrate
InnoVision Marketing Group
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