Optiscan Imaging submits 510(k) application to the US FDA

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Optiscan Imaging (ASX:OIL) has announced the submission to the US FDA of a pre-market notification (510(k)) application for the InVivage device intended for oral tissue imaging.

InVivage is a non-invasive, instantaneous form of oral imaging that targets the severe health consequences of a late-stage diagnosis of oral cancers and precancerous lesions.

The technology platform enables real-time, non-destructive, 3D, in-vivo imaging at the sub-cellular level which aims to provide physicians, surgeons and pathologists with high-resolution microscopic images intraoperatively that can be used to assist with the diagnosis and treatment of various oral pathologies.

Optiscan’s CEO and managing director, Professor Camile Farah, said, “I’m delighted to announce the submission of our 510(k) application for InVivage, a truly landmark achievement for the company. This is a key step towards strengthening the commercialisation of the InVivage device and bringing our revolutionary imaging and real-time pathology technology to the world. This submission strengthens the path for commercialisation of InVivage, which is aligned with our new strategic direction, as we continue to move forward in our go-to-market plans as well as actively look to diversify our product offering.”

Optiscan’s regulatory affairs manager Peter Pavlicek said, “This submission is a significant milestone for the company and a testament to the efforts of our team members who have worked tirelessly to bring this to fruition.”

Chairman Robert Cooke added, “The Board is delighted by this 510(k) submission to the FDA, and looks forward to its clearance in due course. The company will pursue appropriate regulatory approval processes for other markets and will provide further updates on this at a later point in time.”