FDA approves GE optical imaging agent

The U.S. Food and Drug Administration (FDA) has approved an optical imaging agent developed by GE Healthcare of Chalfont St. Giles, U.K., for detecting bladder cancer.

Cysview (hexaminolevulinate HCl) is indicated for use in the cystoscopic detection of nonmuscle-invasive papillary cancer of the bladder among patients suspected of having or known to have lesions on the basis of a prior cystoscopy. It is used with the D-Light C Photodynamic Diagnosis (PDD) system from Karl Storz of Tuttlingen, Germany, to perform cystoscopy with the blue light setting (mode 2) as an adjunct to the white light setting (mode 1).

According to GE, clinical trials indicate that Cysview cystoscopy significantly improves detection of papillary bladder cancer, leading to more complete resection of bladder cancer and improving disease-free survival when compared to white light cystoscopy. GE licensed Cysview from Photocure of Oslo, Norway.

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