By Digifin Pty Ltd · About this coverage
Key Points
- U.S. FDA 510(k) lodged for InVue precision surgery device
- Follows recent InForm digital pathology 510(k) submission announced 1 October 2026
- InVue moves into formal FDA review; clearance not assured
- Company continuing U.S. commercial readiness work alongside the filing
About Optiscan (ASX:OIL)
Optiscan Imaging Limited is an ASX-listed medical imaging company based in Mulgrave, Victoria. It develops confocal endomicroscopy devices for real-time digital pathology and precision surgery applications.
Optiscan (ASX:OIL) lodged a U.S. FDA 510(k) application for its InVue precision surgery device, moving the real-time surgical imaging platform into formal regulatory review after the recently announced InForm 510(k) submission.
InVue is designed to bring microscopic, cellular-level imaging into the operating environment so surgeons can visualise tissue in real time. The company says the filing follows years of technical, clinical and regulatory work and continues commercial readiness through clinical reference sites, customer engagement, manufacturing scale-up and partner discussions. FDA clearance is presented as a gateway to U.S. commercialisation if achieved. The release does not state a review timeline or guarantee clearance.
Source: Optiscan Imaging Limited (ASX:OIL), 5 October 2026. Summary content supplied by Digifin Pty Ltd.
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