Photocure Welcomes FDA Proposal to Initiate the Reclassification of Blue Light Cystoscopy ...

The U.S. FDA has proposed reclassifying blue light cystoscopy systems for bladder cancer detection from Class III to Class II, reflecting sufficient evidence of safety and effectiveness to allow a less burdensome regulatory pathway. This move aims to expand access, support innovation, and facilitate broader adoption of blue light cystoscopy technology in the U.S.

This Wire brief sits within Fusion42's coverage of Medtech.