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 integrated OptraSCAN System. The clearance covers the OS-Ultra Whole Slide Scanner, a colour display monitor and a workstation running ImagePath Image Management Software, including HER2 Image Analysis Software, enabling pathologists to review and assess HER2 expression in clinical practice.
HER2 assessment is an important component of breast cancer diagnosis and helps guide treatment decisions. With pathology laboratories increasingly adopting digital workflows, image analysis technologies are playing a growing role in improving consistency, efficiency and reproducibility in pathology review.
The regulatory approval marks a significant milestone for OptraSCAN following years of product development, engineering and clinical validation. It also reinforces the strategic value of Molbio Diagnostics’ investment in the company, expanding its portfolio of clinically validated diagnostic technologies while demonstrating its commitment to meeting the stringent regulatory standards of the U.S. FDA.
“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.”
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.”
