Optiscan has been featured in Stockhead, highlighting the lodgement of a US FDA 510(k) submission for its InVue precision surgery platform, following the company’s recent submission for its InForm digital pathology device.
The article outlines how InVue is designed to provide surgeons with real-time, cellular-level microscopic images of tissue while a patient remains in theatre, with an initial focus on surgical oncology. It highlights the potential application of the technology across breast, head and neck and other solid tumour procedures, while also noting that the submission moves InVue into formal FDA regulatory review. Together with the earlier InForm filing, Optiscan now has two devices progressing through the US 510(k) pathway as it continues clinical, manufacturing and commercial preparations for potential US market entry.
CEO and Managing Director Dr. Camile Farah said: “The InVue submission, along with the earlier FDA submission for the InForm digital pathology device, are both powerful validations of how far our platform has progressed.”
He added: “From breast and head and neck cancer to other solid tumour procedures, the opportunity is to bring cellular-level information directly into the operating theatre where life-changing decisions need to be made.”
Stockhead – Read the full article here.