INDIA – July 21, 2026: OptraSCAN, Inc., a California-headquartered digital pathology and image analysis company in which Molbio Diagnostics Limited acquired a majority stake in 2025, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance (K260755) for the OptraSCAN System. The clearance covers the integrated OptraSCAN System comprising the OS-Ultra Whole Slide Scanner, a color display monitor, and a workstation running the company’s ImagePath Image Management Software, including HER2 Image Analysis Software. Together, the system supports pathologists in the review and assessment of HER2 expression in clinical practice.
HER2 assessment plays a critical role in breast cancer characterisation and therapeutic decision-making. As pathology laboratories worldwide continue to transition towards digitised workflows, image analysis technologies are increasingly adopted to support standardisation, reproducibility, and efficiency in pathology review processes.
The FDA 510(k) clearance represents a significant milestone for OptraSCAN and reflects years of product development, engineering and clinical validation across its global teams. The achievement also highlights the value of Molbio Diagnostics’ strategic investment in OptraSCAN, expanding its portfolio of clinically validated diagnostic technologies. It further demonstrates the group’s commitment to developing diagnostic solutions that meet the rigorous regulatory standards of the U.S. Food and Drug Administration.
“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.”
Commenting on the significance of the development for the global pathology community, Dr. Reena Nakra, Chief Scientific Officer, Dr Lal PathLabs, said, “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.”
About OptraSCAN
Headquartered in California, USA, OptraSCAN is engaged in the business of automating scanning device technology with tumor and immune cell intelligent scoring systems, dedicated to transforming the future of pathology services through advanced digital slide scanners & AI-driven solutions. It provides digital pathology solutions, offering a range of digital pathology scanners, AI-powered analysis tools, and telepathology services, enabling remote consultations and collaboration.
About Molbio Diagnostics Limited:
Molbio Diagnostics Limited is an innovative point-of-care diagnostics company. With a commitment to providing rapid, accurate, and cost-effective diagnostic solutions. The company’s flagship Truenat®️ real-time PCR platform is globally recognised and endorsed by the World Health Organisation (WHO), enhancing infectious disease management worldwide. Molbio is dedicated to improving healthcare accessibility and quality with innovative diagnostics that meet global standards.
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