Photocure Welcomes FDA Proposal to Initiate the Reclassification of Blue Light Cystoscopy Systems from Class III to Class II

Photocure announced the FDA has published a proposed Federal Register order to initiate the reclassification process for cystoscopic systems intended for bladder cancer use. The filing represents a regulatory progression that could support future commercialization pathways, but the company did not provide an approval/timing outcome in the release.

Analysis

Photocure announced the FDA has published a proposed Federal Register order to initiate the reclassification process for cystoscopic systems intended for bladder cancer use. The filing represents a regulatory progression that could support future commercialization pathways, but the company did not provide an approval/timing outcome in the release.