Oslo, Norway, August 14, 2026
Photocure ASA has welcomed a new proposal from the U.S. Food and Drug Administration (FDA) to begin reclassifying cystoscopic systems used as an aid in the detection of bladder cancer from Class III to Class II medical devices. The proposed order, published in the Federal Register, follows the FDA’s review of available scientific, clinical, and post-market evidence. According to the agency’s assessment described by Photocure, sufficient information is available to establish special controls that, together with general controls, could provide reasonable assurance of the safety and effectiveness of these devices. The proposed change represents an important regulatory development for Blue Light Cystoscopy (BLC®) and could influence future access to compatible cystoscopic technologies in the United States.
FDA Proposes New Regulatory Framework for BLC Systems
The proposed reclassification applies to cystoscopic systems intended for use with an approved optical imaging agent during photodynamic Blue Light Cystoscopy as an adjunct to White Light Cystoscopy. The systems are intended to aid detection of known or suspected bladder cancer, including carcinoma in situ, as well as surveillance cystoscopy for patients with bladder cancer. Photocure said the FDA initiated the proposed reclassification on its own initiative after reviewing regulatory history, clinical evidence, scientific literature, and available post-market safety information. If finalized, the proposed framework would move applicable cystoscopic systems from the current Class III premarket approval (PMA) pathway to Class II with special controls, with premarket notification through the 510(k) pathway. The FDA is not proposing to exempt these devices from 510(k) requirements. Instead, the agency is proposing to establish a new device classification specifically for cystoscopic systems intended as an aid in bladder cancer detection. Until a final order becomes effective, the systems will remain subject to their existing regulatory classification and requirements.
BLC and Cysview Support Bladder Cancer Detection
Blue Light Cystoscopy with Cysview® is an established adjunct to white light cystoscopy for detecting non-muscle invasive bladder cancer (NMIBC). Cysview is an FDA-approved optical imaging agent that is administered into the bladder before cystoscopy. Under blue light, malignant lesions can fluoresce, helping physicians visualize abnormalities that may not be readily apparent under white light alone. Photocure states that BLC with Hexvix/Cysview can improve tumor detection and support more complete tumor resection and treatment decisions. Bladder cancer has a substantial recurrence burden, requiring many patients to undergo repeated cystoscopic surveillance. The company notes that approximately 75% of bladder cancer cases are non-muscle invasive, making accurate detection and ongoing monitoring important components of patient management. The potential availability of additional cystoscopic equipment platforms compatible with BLC could therefore support broader adoption of the technology across healthcare settings.
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Proposed Reclassification Could Expand BLC Access
Photocure believes that the proposed transition to Class II regulation could encourage innovation and support the development of additional standalone and add-on cystoscopic equipment platforms in the United States. Greater equipment availability could give more hospitals and physicians the opportunity to incorporate BLC into clinical practice while supporting efforts to expand patient access and generate additional clinical and health-economic evidence. The proposal also represents a notable medical-device regulatory milestone because it reflects the FDA’s consideration of the maturity and established clinical use of BLC technology. Photocure said the agency’s review included information from the original PMA, peer-reviewed literature, the 2009 Oncologic Drugs Advisory Committee meeting concerning Cysview, post-market safety information, and subsequent regulatory submissions. The company also highlighted the absence of significant post-market safety signals described in the FDA’s review.
The proposed reclassification remains subject to the applicable FDA regulatory process, including a public comment period and agency consideration of submitted comments before any final order is issued. If finalized, the new classification could create a more accessible regulatory pathway for future BLC-compatible cystoscopic systems while maintaining special controls intended to support device safety and effectiveness. For the bladder cancer community, the development could contribute to greater availability of advanced optical imaging technology for cancer detection and surveillance.
Source: Photocure press release
