OptraSCAN Inc., a California-headquartered digital pathology and image analysis company in which Molbio Diagnostics Limited acquired a majority stake in 2025, has received U.S. Food and Drug Administration (FDA) 510(k) clearance (K260755) for its 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. The system is designed to assist pathologists in the review and assessment of HER2 expression, an important biomarker used in breast cancer diagnosis and treatment planning.

HER2 evaluation plays a critical role in characterising breast cancer and guiding therapeutic decisions. As pathology laboratories increasingly adopt digital workflows, image analysis technologies are helping improve standardisation, reproducibility and efficiency in pathology review.

The FDA 510(k) clearance marks a major milestone for OptraSCAN following years of product development, engineering and clinical validation. The company said the approval also reflects the strategic value of Molbio Diagnostics' investment in expanding its portfolio of clinically validated diagnostic technologies and reinforces the group's commitment to developing solutions that meet stringent U.S. regulatory standards.

Abhi Gholap, Founder and CEO of OptraSCAN, said, "This FDA clearance is an important milestone in our journey to advance digital pathology globally. 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, 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."