Optiscan Imaging lodges 510k application with US FDA

• Optiscan Imaging has submitted a 510(k) application to the U.S. FDA for its InForm digital pathology device.
• Following the regulatory filing, the company's share price traded at $0.135.
• The submission marks a step towards commercialising the digital pathology platform in the U.S. market.

Optiscan Imaging (ASX:OIL) has lodged a 510(k) submission with the U.S. Food and Drug Administration for its InForm digital pathology device.

The regulatory filing follows the completion of technical, clinical, and regulatory preparation for the digital pathology system.

The company stated that the submission represents a milestone in its plans to digitalise pathology imaging.

As part of the clearance process, Optiscan plans to build its clinical reference network and deepen engagement with potential commercial partners.

Following the announcement, the Optiscan Imaging share price was unchanged at $0.135.

The company focuses on developing microscopic imaging technologies for real-time, non-destructive digital pathology.

Its proprietary technology is designed to enable real-time digital imaging during medical and surgical procedures.