OptraSCAN, Inc., a California-based digital pathology and image analysis company majority-held by Molbio Diagnostics Limited since 2025, has received U.S. Food and Drug Administration 510(k) clearance (K260755) for the OptraSCAN System. The clearance covers the integrated solution comprising the OS‑Ultra Whole Slide Scanner, a color display monitor and a workstation running OptraSCAN’s ImagePath Image Management Software, including HER2 Image Analysis Software. The system is cleared to support pathologists in reviewing and assessing HER2 expression in clinical practice.
HER2 assessment is central to breast cancer characterisation and therapeutic decision-making. As pathology laboratories worldwide shift to digitised workflows, image analysis tools are being adopted to improve standardisation, reproducibility and efficiency in pathology review.
The FDA 510(k) clearance marks a major milestone for OptraSCAN after years of product development, engineering and clinical validation across its global teams. The approval also underscores the strategic value of Molbio Diagnostics’ majority investment in OptraSCAN, expanding the group’s portfolio of clinically validated diagnostic technologies and reflecting its commitment to solutions that meet U.S. regulatory standards.
“This FDA clearance is an important milestone in our journey to advance digital pathology globally,” said Abhi Gholap, Founder and CEO of OptraSCAN. “As digital pathology adoption continues to accelerate worldwide, the FDA clearance further strengthens OptraSCAN’s position as a trusted technology partner for hospitals, diagnostic laboratories, academic medical centres, and life sciences organisations. It also underscores the company’s continued investment in innovation through its global teams across the United States and India.”
Dr. Reena Nakra, Chief Scientific Officer at Dr Lal PathLabs, welcomed the development, saying, “Digital pathology is becoming an increasingly important part of modern pathology. We have had the opportunity to work with OptraSCAN and regulatory milestones such as U.S. FDA clearance provide additional confidence in the quality of its digital pathology platform and the clinical robustness of this technology. This milestone is an encouraging step forward for the continued adoption of digital pathology.”
