Optiscan has been featured in a Stockhead article, highlighting the company’s lodgement of a US FDA 510(k) submission for its InForm digital pathology platform, moving the device into formal regulatory review.

The article outlines the technical, clinical and regulatory work completed to support the submission and highlights InForm’s differentiated approach to digital pathology, enabling real-time, slide-free microscopic imaging directly from fresh or fixed tissue without relying on the conventional glass-slide workflow. It also discusses the commercial opportunity in the US pathology market, Optiscan’s ongoing clinical evidence generation and the company’s plans to establish clinical reference sites and continue commercial readiness activities while the FDA review progresses.

CEO and Managing Director Dr. Camile Farah said: “InForm represents one of the most exciting opportunities within our portfolio.”

He added: “The device is not just digitising an existing pathology process. It has real potential to change where and when microscopic information becomes available for clinical use.”

Dr Farah also said: “Lodging our FDA submission brings us closer to introducing a fundamentally different workflow into the U.S., one of the world’s largest pathology markets.”

Stockhead – Read the full article here.