FDA proposes reclassifying Photocure’s blue light cystoscopy systems
The US FDA has proposed reclassifying blue light cystoscopy (BLC) systems used with Photocure’s imaging agent Cysview for bladder cancer detection from Class III to Class II, a move the Norwegian medtech company says will support wider adoption of the technology in US hospitals.
August 25, 2026
The reclassification would shift BLC systems from the stricter premarket approval (PMA) pathway to a 510(k) notification pathway, while special controls would still apply. Photocure says this reflects the FDA’s own conclusion that there is now sufficient information to establish such controls, given BLC’s maturity and established clinical use. The proposal is subject to a public comment period and regulatory review, and current Class III requirements remain in force until a final order takes effect.
“FDA’s decision to initiate the reclassification process on its own initiative reflects the Agency’s conclusion that there is sufficient information to establish special controls,” says Dan Schneider, CEO, Photocure.
Published: August 25, 2026
