FDA Approves Cysview for Detecton of Bladder Cancer

GE Healthcare, a unit of General Electric Company (NYSE:GE), has announced that the US Food and Drug Administration (FDA) has approved Cysview(TM) (hexaminolevulinate HCl) for the detection of non-muscle-invasive papillary cancer of the bladder in patients with known or suspected bladder cancer. Cysview is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle-invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform cystoscopy with the blue light setting (Mode 2) as an adjunct to the white light setting (Mode 1). "Phase III clinical data supplied with the New Drug Application demonstrated a significantly improved rate of detection of non-muscle-invasive papillary cancer using Cysview cystoscopy compared to standard white light cystoscopy alone in patients with non-muscle-invasive papillary bladder cancer," said Eric Cantor, MD, Head of Medical Affairs for GE Healthcare's Medical Diagnostics Business in the Americas. "The use of Cysview and blue light cystoscopy enables physicians to detect bladder tumors more accurately than with standard white light technology. The introduction of Cysview is a reflection of our commitment to providing innovative advances in diagnostic oncology."