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 Silicon Valley medical technology company, revealed today that it has achieved ISO 13485 certification from the British Standards Institution (BSI), reaching a crucial commercialization milestone in the medical device industry and propelling its noninvasive skin cancer detection system, AURA™, closer to regulatory clearances and eventual market availability.
ISO 13485 certification, granted by a globally recognized leader in standards and certification, confirms that Vita Imaging’s quality management system meets the stringent requirements for designing, developing, and manufacturing medical technology that adheres to internationally accepted quality benchmarks. This accomplishment lays the groundwork for regulatory approvals, scaled production, strategic alliances, and future worldwide expansion for the company.
Vita Imaging’s innovative platform, AURA, is a noninvasive imaging system that enables physicians to examine suspicious skin lesions in under 1.5 seconds using proprietary Raman spectroscopy. By delivering additional objective data during patient consultations, AURA aims to strengthen 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 step in Vita Imaging’s wider regulatory strategy. 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 works toward CE Mark certification for AURA in Europe. With ISO 13485 certification now in hand, Vita Imaging will continue progressing regulatory approvals while getting ready for commercial manufacturing and market entry.
This accomplishment builds on more than two decades of research and development behind Vita Imaging’s proprietary technology and reflects the company’s ongoing progress toward reshaping how skin cancer is identified. By offering rapid, noninvasive assessments at the point of care, Vita Imaging believes AURA can help physicians reach more confident clinical decisions while enhancing 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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