Mumbai: Digital pathology company OptraSCAN, Inc., a California-headquartered healthcare technology firm in which Molbio Diagnostics Limited acquired a majority stake in 2025, has achieved a significant regulatory milestone after receiving U.S. Food and Drug Administration (FDA) 510(k) clearance for its integrated OptraSCAN System.
The clearance covers the complete 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 integrated platform supports pathologists in reviewing and assessing HER2 expression in breast cancer tissue, helping improve diagnostic workflows.
HER2 assessment plays an important role in breast cancer characterisation and treatment planning. As healthcare systems across the world increasingly adopt digital pathology, AI-powered image analysis is becoming a valuable tool for improving consistency, efficiency, and reproducibility in pathology laboratories.
The FDA 510(k) clearance marks a major achievement for OptraSCAN following years of engineering, clinical validation, and product development. It also reinforces the strategic value of Molbio Diagnostics’ investment in expanding its portfolio of globally validated diagnostic technologies.
Commenting on the achievement, Abhi Gholap, Founder and CEO of OptraSCAN, said the regulatory clearance represents an important step in advancing digital pathology worldwide.
“As digital pathology adoption continues to accelerate globally, this 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 reflects our continued investment in innovation through our teams across the United States and India.”
The development was also welcomed by pathology experts.
Dr. Reena Nakra, Chief Scientific Officer at Dr Lal PathLabs, said digital pathology is becoming increasingly important in modern healthcare.
“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, OptraSCAN develops advanced digital pathology scanners, AI-powered image analysis solutions, and telepathology technologies that enable remote pathology consultation and collaboration.
About Molbio Diagnostics
Molbio Diagnostics Limited is a leading point-of-care diagnostics company known globally for its Truenat® real-time PCR platform, endorsed by the World Health Organization (WHO). The company continues to expand its portfolio of innovative diagnostic technologies aimed at improving healthcare accessibility worldwide.
Regulatory Note: The announcement relates to an FDA 510(k) clearance, not FDA approval. The OptraSCAN System is cleared specifically for the clinical use described in the regulatory filing concerning HER2 scoring in breast tissue and should not be interpreted as approval for broader diagnostic applications.
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