- 01InVue 510(k) filed with FDA.
- 02Device delivers real-time, cellular-level imaging in surgery.
- 03Clearance could open US market; follows InForm filing.
Optiscan Imaging (ASX: OIL) has submitted a 510(k) application with the US Food and Drug Administration for its InVue advanced microscopic medical imaging device, which allows surgeons to view tissue at a cellular level in real time while a patient is still on the operating table.
Bringing together detailed evidence on device performance, safety, verification and validation, risk management, and clinical use, the submission moves InVue into formal independent regulatory review.
The news, which follows a similar submission earlier this month for the InForm digital pathology device, marks an important step toward regulatory clearance of the company’s flagship real-time surgical imaging platform.
FDA clearance is a critical gateway to commercialisation in the US, and would position Optiscan to progress InVue from an advanced clinical-stage technology toward commercial market entry.
The US represents a substantial surgical oncology opportunity for Optiscan, with approximately 60% of cancer patients undergoing surgery to treat or stage their disease and equivalent to around 1.27 million patients annually based on 2026 cancer statistics.
In-Theatre Imaging
InVue has been developed to bring microscopic cellular-level imaging directly into the sterile operating environment, enabling surgeons to visualise tissue in real time while a patient is in theatre and determine whether suspicious or residual tumour remains.
The device is designed to eliminate the conventional process of removing tissue and sending it away for laboratory preparation before review.
By providing information at the point at which surgical decisions are being made, InVue has the potential to support a more informed assessment of tissue and surgical margins across a range of procedures and clinical specialties.
Surgical oncology represents a particularly compelling initial target healthcare market segment for Optiscan, given the scale and diversity of cancer surgery across disciplines including breast, head and neck, colorectal, genitourinary, skin, and other solid tumour procedures.
It is estimated to be the largest segment of the US cancer treatment facilities market, representing an estimated US$4.8 billion in annual revenue, while the broader intraoperative imaging market is forecast to reach US$1.55 billion by 2030.
Key Company Deliverable
Managing director Dr Camile Farah said lodgement of InVue’s 510(k) submission represented another key deliverable in the company’s broader development strategy.
“It means we are now much closer to making a technology designed to give surgeons microscopic insight in real-time commercially available in the world’s most important healthcare markets,” she said.
“InVue potentially offers multiple advantages to surgeons and could change what they can see and when they can see it, providing them with a better course of action during surgery.
“The opportunity is to bring cellular-level information directly into the operating theatre where life-changing decisions need to be made—that is a compelling clinical proposition and a significant commercial opportunity as we build toward our US market entry.”
The company continues to advance commercial readiness for InVue through clinical reference sites, customer engagement, manufacturing scale-up, and discussions with commercial partners.
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