Photocure Sees Potential in US FDA's Proposed Reclassification of Cystoscopy Systems

MT Newswires · 2d ago
06:16 AM EDT, 08/16/2026 (MT Newswires) -- Photocure (PHO.OL) said Aug. 14 that the US Food and Drug Administration proposed to reclassify cystoscopic systems for bladder cancer detection to class II from class III. The bladder cancer-focused company anticipates that the proposed order will enable the development and introduction of additional standalone and add-on cystoscopic equipment platforms in the US. The reclassification is subject to a regulatory process, including a public comment period.