This regulatory adjustment follows the FDA’s own review of scientific and clinical history, concluding that sufficient controls now exist to ensure device safety without maintaining the more stringent Class III premarket approval pathway. By transitioning to a 510(k) framework, the agency aims to streamline the path for new equipment platforms, which Photocure executives believe will catalyze innovation and broaden physician access to the technology.
FDA Proposes Shifting Blue Light Cystoscopy Systems to Class II
The U.S. Food and Drug Administration has initiated a move to reclassify blue light cystoscopy systems from Class III to Class II, signaling a shift in how the agency regulates diagnostic tools used for bladder cancer detection after reviewing decades of clinical evidence and post-market safety data.
For Photocure, the decision validates the maturity of its Cysview-based diagnostic process. The company expects the change to lower barriers for hospitals to adopt blue light cystoscopy, allowing for more competition in equipment development and wider integration into standard clinical practice. While the proposal marks a milestone, the current regulatory requirements remain in effect until the FDA completes its public comment period and issues a final order.
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