PR Newswire Regulatory and legal
Photocure Welcomes FDA Proposal to Initiate the Reclassification of Blue Light Cystoscopy Systems from Class III to Class II
OSLO, Norway, Aug. 14, 2026 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, today announced that the U.S. Food and Drug Administration (FDA) has published a proposed order in the Federal Register to initiate the process of reclassifying cystoscopic systems intended as an aid for the detection of bladder cancer from Class III to Class II. โฆ