OptraSCAN, a California-headquartered digital pathology and image analysis company backed by Molbio Diagnostics, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its integrated OptraSCAN System. The regulatory approval marks a significant milestone for the company as it strengthens its presence in the rapidly growing digital pathology market.
The FDA clearance covers the complete OptraSCAN System, including the OS-Ultra Whole Slide Scanner, a colour display monitor, and a workstation equipped with ImagePath Image Management Software and HER2 Image Analysis Software. The integrated platform is designed to support pathologists in evaluating HER2 expression, an important biomarker used in breast cancer diagnosis and treatment planning.
HER2 testing plays a crucial role in determining treatment strategies for breast cancer patients. As pathology laboratories continue adopting digital workflows, AI-powered image analysis platforms are helping improve diagnostic consistency, workflow efficiency, and clinical decision-making. The clearance enables OptraSCAN to offer a clinically validated solution that supports modern pathology practices and enhances diagnostic accuracy.
Commenting on the achievement, Abhi Gholap, Founder and CEO of OptraSCAN, said the FDA clearance represents a major milestone in the company’s mission to advance digital pathology globally. He noted that the approval further strengthens OptraSCAN’s position as a trusted technology partner for hospitals, diagnostic laboratories, academic medical centres, and life sciences organisations while reinforcing its commitment to innovation through its teams in the United States and India.
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Dr. Reena Nakra, Chief Scientific Officer at Dr Lal PathLabs, said regulatory milestones such as U.S. FDA clearance provide greater confidence in the quality and clinical robustness of digital pathology platforms. She added that the approval is an encouraging development for the continued adoption of digital pathology technologies across healthcare institutions.
The achievement also highlights the strategic value of Molbio Diagnostics’ majority investment in OptraSCAN, completed in 2025. By expanding its portfolio of clinically validated diagnostic technologies, Molbio continues to strengthen its position in advanced diagnostics while supporting the global shift toward AI-enabled, digitally connected pathology solutions.
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