OptraSCAN, a California-headquartered digital pathology and image analysis company in which Molbio Diagnostics acquired a majority stake in 2025, has received US Food and Drug Administration (FDA) 510(k) clearance (K260755) for the OptraSCAN System.
According to the company, the clearance covers the integrated OptraSCAN System, comprising the OS-Ultra Whole Slide Scanner, a colour display monitor and a workstation running the company’s ImagePath Image Management Software, including HER2 Image Analysis Software. The company stated that the system is designed to support pathologists in the review and assessment of HER2 expression in clinical practice.
According to OptraSCAN, HER2 assessment plays a role in breast cancer characterisation and treatment decision-making. The company stated that as pathology laboratories continue to adopt digital workflows, image analysis technologies are being used to support standardisation, reproducibility and workflow efficiency during pathology review.
The company stated that the FDA 510(k) clearance follows product development, engineering and clinical validation across its global teams. According to OptraSCAN, the clearance also reflects Molbio Diagnostics’ investment in the company and expands its portfolio of diagnostic technologies. The company added that the milestone demonstrates its focus on developing diagnostic solutions that meet US FDA regulatory requirements.
Commenting on the clearance, Abhi Gholap, Founder and Chief Executive Officer, 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.”
Commenting on the development, 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.”