Optiscan Lodges U.S. FDA 510(k) Submission for InVue

• Optiscan has submitted a 510(k) application to the FDA for InVue®.
• This follows the recent submission for InForm®.
• InVue® aims to bring real-time microscopic imaging to surgery.
• Successful FDA clearance could enable U.S. market entry.
• InVue® targets a significant surgical oncology opportunity.

Optiscan Imaging Ltd (ASX: OIL) has lodged a 510(k) application with the U.S. Food and Drug Administration (FDA) for its InVue precision surgery device. This follows the recent submission for Optiscan's InForm digital pathology device. The InVue submission represents the culmination of extensive technical, performance, and clinical development and moves the device into formal independent regulatory review. FDA clearance is a critical gateway to commercialization in the U.S., and if achieved, would position Optiscan to progress InVue from an advanced clinical-stage technology toward commercial market entry. InVue is designed to bring microscopic, cellular-level imaging directly into the operating environment, enabling surgeons to visualize tissue in real time while the patient remains in theatre. The U.S. represents a substantial surgical oncology opportunity, with approximately 60% of cancer patients undergoing surgery to treat or stage their disease, equivalent to around 1.27 million patients annually based on 2026 cancer incidence.

Optiscan anticipates that FDA clearance for InVue would enable commercialization in the U.S., opening a significant market opportunity in surgical oncology.