India, July 20 -- OptraSCAN, Inc., 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.

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. Together, the system supports pathologists in the review and assessment of HER2 expression in clinical practice.

HER2 assessment plays a critical role in breast cancer characterisation and therapeutic decision-making. As pathology l...