Optiscan Imaging Lodges Submission Seeking US FDA Approval for Digital Pathology Device; Shares Rise 4%
MT Newswires Live
Yesterday
Optiscan Imaging (ASX:OIL) lodged a 510(k) submission with the US Food and Drug Administration (FDA) for its InForm medical imaging device designed for pathology workflows, according to a Thursday filing with the Australian bourse.
The submission moves the device beyond its internal development, testing, and validation phase into a formal regulatory assessment process, with clearance being a precursor to its commercial marketing within the US.
The company said the US represents a "substantial commercial opportunity" for InForm given that its pathology market is still largely analogue and is only now starting to shift toward digital workflows.
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