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

• Optiscan has submitted a 510(k) to the U.S. FDA for its InForm device
• This is a necessary step for regulatory approval and commercialization
• InForm aims to revolutionize pathology workflows by offering real-time, slide-free imaging

Optiscan Imaging Ltd (ASX: OIL) has submitted a 510(k) to the U.S. FDA for its InForm digital pathology device. This submission follows extensive technical, clinical, and regulatory work and represents a significant milestone in the device's development. InForm is designed to enable real-time, slide-free digital microscopic imaging, potentially transforming pathology workflows. The U.S. pathology market, valued at approximately US$10.6 billion in 2025 and forecast to reach US$15.35 billion by 2030, offers a substantial opportunity. Successful FDA clearance would enable commercial distribution of InForm in the U.S., advancing Optiscan's commercialization strategy.