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/ — Vita Imaging, a medical technology firm based in Silicon Valley, announced today that it has obtained ISO 13485 certification from the British Standards Institution (BSI). This milestone marks one of the most critical steps toward commercialization in the med-tech sector and moves the company’s groundbreaking, noninvasive skin cancer detection platform, AURA™, closer to regulatory clearances and eventual market entry.
Issued by a globally recognized leader in standards and certification, ISO 13485 confirms that Vita Imaging’s quality management system meets the stringent requirements 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.
Vita Imaging’s innovative AURA platform is a noninvasive imaging system that enables physicians to assess suspicious skin lesions in less than 1.5 seconds using proprietary Raman spectroscopy technology. By delivering additional objective data during clinical evaluations, AURA aims to boost diagnostic certainty, guide more informed biopsy decisions, and improve 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 key advance in Vita Imaging’s overall regulatory approach. BSI, a widely respected Notified Body under the European Union Medical Device Regulation (EU MDR), will act as the company’s regulatory partner as it seeks CE Mark approval for AURA in Europe. With ISO 13485 now in hand, Vita Imaging will push forward with additional regulatory clearances while gearing up for commercial manufacturing and product launch.
This achievement is built on more than two decades of research and development behind Vita Imaging’s proprietary technology and underscores the company’s steady progress toward redefining skin cancer detection. By providing fast, noninvasive assessments at the point of care, Vita Imaging believes AURA can empower physicians to make more confident clinical choices and enhance patient outcomes through earlier diagnosis.
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
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