Bladder cancer is the sixth most common cancer in the U.S. and the most expensive type to treat over the lifetime of a patient. The conventional method of detecting bladder cancer uses white light during minimally invasive surgery to illuminate the bladder during a procedure called a cystoscopy. In typical white light cystoscopy, a small camera is mounted at the end of the cystoscope. This enters the body through the urethra into the bladder and projects images onto a surgical monitor. The procedure easily visualizes tumors that protrude above the bladder wall for evaluation and possible removal. However, when a tumor lies flat against the bladder wall, it is difficult to identify the margins and differentiate from normal tissue. This increases the risk of cancerous cells being left behind, contributing to bladder cancer’s more than 50% recurrence rate.

Blue light cystoscopy, introduced in 2010, uses blue-filtered white light to address the limitations of white light cystoscopy. This method involves administering a contrast agent into the bladder which is absorbed by the cancerous cells, causing them to fluoresce when exposed to blue light. Surgeons are then able to view images of the highlighted cancer cells and more effectively identify flat tumors and their margins for removal. While blue light cystoscopy provides sharper images of the cancer, surgeons still need white light images to get proper orientation within the bladder. Because current technology can only project one image at a time on the surgical monitor, surgeons must switch back and forth between blue and white light images and rely on memory to resect. Another limitation of this method requires the purchase of new proprietary blue-filter endoscopes that cannot be used for any other purpose. Now, a state-of-the-art visualization technology addresses the limitations of both white and blue light cystoscopy while maintaining the advantages of both.

Imagin Medical’s (Auburndale, MA, USA) i/Blue Imaging System combines innovative optical filtering technology with the same FDA-approved imaging agent, allowing surgeons to view real-time, side-by-side white and blue light images on the same monitor, eliminating the need to switch back and forth. This method has the potential to make bladder cancer detection and removal more efficient and accurate, as well as reduce recurrence rates and health care costs. Unlike current bladder cancer visualization systems, the i/Blue Imaging System is a device external to the body with the capability to attach to most fiberoptic endoscopes currently on the market. As a result, hospitals will be able to integrate Imagin’s technology with endoscopes they already own. While the current blue light method requires a system tower that houses the light source, camera control and video data recorder units, the i/Blue Imaging System consolidates this instrumentation, combining these three modules into one compact device. Imagin has developed functional units of its i/Blue Imaging System which, when bench tested, met FDA standards and exceeded goals for product performance. The company has defined a regulatory path to achieve FDA approval. 

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