Mumbai: OptraSCAN, a California-headquartered digital pathology and image analysis company in which Molbio Diagnostics Limited acquired a majority stake in 2025, has 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. The system is designed to support pathologists in the review and assessment of HER2 expression in clinical practice.
OptraSCAN system supports HER2 assessment in breast cancer
HER2 assessment plays a critical role in breast cancer characterization and therapeutic decision-making.
As pathology laboratories worldwide continue to transition toward digitized workflows, image analysis technologies are increasingly being adopted to support standardization, reproducibility, and efficiency in pathology review processes.
The FDA 510(k) clearance marks a significant regulatory milestone for OptraSCAN and reflects years of product development, engineering, and clinical validation across the company’s global teams.
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Strategic significance for Molbio Diagnostics and OptraSCAN
The clearance also highlights the value of Molbio Diagnostics Limited’s strategic investment in OptraSCAN, expanding its portfolio of clinically validated diagnostic technologies.
According to the company, the achievement 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,” he added.
Pathology experts welcome the OptraSCAN milestone
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.”
The FDA clearance positions OptraSCAN among the companies with regulatory authorization for integrated digital pathology systems intended to assist pathologists in HER2 review and assessment workflows.
