Photocure welcomes FDA proposal to reclassify blue light cystoscopy systems to Class II

• Photocure backed an FDA proposal to reclassify blue light cystoscopy systems from Class III to Class II with special controls.
• The shift would move applicable systems from the PMA pathway to 510(k) clearance, keeping premarket notification requirements.
• FDA initiated the reclassification on its own review of clinical, regulatory, and post-market evidence, citing no significant safety signals.
• The proposal targets systems used with an approved optical imaging agent as an adjunct to white light cystoscopy for bladder cancer detection.
• Photocure expects the change to expand US access and accelerate adoption by enabling more compatible equipment platforms.

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 via Cision (Ref. ID: 20260814:BIT:8047:0) on August 14, 2026, and is solely responsible for the information contained therein.