Photocure ASA, The Bladder Cancer Company, announced that the U.S. Food and Drug Administration (FDA) approved of a new and improved Blue Light system to be used with Photocure’s Cysview® product in Blue Light Cystoscopy (BLC®) procedures for the detection of NMIBC*. Manufactured and soon to be commercialized by KARL STORZ Endoscopy-America, Inc. (KARL STORZ), the new Blue Light system is approved for use in procedures requiring rigid cystoscopy. FDA approval was granted to KARL STORZ on February 4, 2022.
“The successful FDA approval is great news for the bladder cancer community in the U.S.,” commented Geoffrey Coy, Vice President and General Manager, North America at Photocure. “In healthcare, constant technical innovation is crucial, and we expect that this new, enhanced BLC system will fulfill our clients’ expectations for improving the Blue Light experience. The new system is the next generation and includes practical features to make the technology more user friendly. We look forward to expanding the use of BLC with Cysview®,” Geoffrey Coy concluded.
“At KARL STORZ, we are committed to helping our customers deliver top-quality care, and we believe that our new Blue Light system demonstrates this commitment,” said Michael Lyman, Executive Director, Sales & Marketing, Urology and Gynecology, KARL STORZ Endoscopy-America. “The New Blue Light Powered by Saphira® will allow us to serve the needs of our customers, providing next-level visualization to enable the right solutions for urological procedures in patients with Non-Muscle Invasive Bladder Cancer and continue our collaboration with the Photocure team to make high-quality BLC available to more patients in the U.S.”.
Photocure expects to inform its stakeholders about the launch of the new Blue Light system as KARL STORZ provides further information regarding the product and its launch plans.