Photocure says FDA proposes shifting blue light cystoscopy systems to Class II from Class III

• FDA published a proposed order to reclassify blue light cystoscopy systems for bladder cancer detection from Class III to Class II.
• Finalized change would shift affected systems from the PMA route to 510(k) clearance with special controls, keeping premarket notification.
• Proposal covers systems used with an FDA-approved optical imaging agent as an adjunct to white light cystoscopy for known or suspected cases.
• Reclassification remains subject to public comment; current Class III requirements stay in force until a final order takes effect.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Photocure ASA published the original content used to generate this news brief on August 14, 2026, and is solely responsible for the information contained therein.