Photocure Announces FDA Approval of New Drug Application for Blue Light Cystoscopy with Cysview®

February 16, 2018

February 16, 2018– Today Photocure ASA announced the FDA approval of new indications for Blue Light Cystoscopy (BLC™) with Cysview®.  This supplemental new drug application (sNDA) will include Flexible Cystoscopes, which are used in the ongoing surveillance of bladder cancer patients bladder cancer. It is the only combination of drug and device approved for the detection of this disease.

“This expanded approval in both rigid and flexible blue light cystoscopy (BLC) means that Cysview can now be used during transurethral resection of bladder cancer surgery for diagnosis and staging, as well as with follow-up surveillance of non-muscle invasive bladder cancer (NMIBC).”

Gary Steinberg, MD, The University of Chicago