Olympus has obtained 510(k) approval from the US Food and Drug Administration for its Narrow Band Imaging (NBI), a patented endoscopic light technology that enables effective targeting of biopsies without the use of dyes or drugs.
According to the company, NBI allows effective targeting of biopsies not seen under white light and improved visualization of tumor boundaries in Non-Muscle-Invasive Bladder Cancer (NMIBC) patients.
NBI uses only blue and green, unlike white light that uses all colors in the spectrum, and it enhances visibility of vascular structures on the mucosal surface.
Olympus Corporation of the Americas’ Medical Systems Group sales, marketing and shared services executive vice-president Richard Reynolds said: "We are excited to offer NBI to the urologic community and share this new development with primary care physicians who can refer patients to urologists using NBI.
"We believe that NBI has the potential to revolutionize how bladder cancer is detected and treated, helping our customers meet the triple aim of healthcare reform by improving quality of care, decreasing costs and enhancing patient satisfaction."
Olympus noted that NBI can be used for NMIBC in the office or clinic for cystoscopy (diagnosis) and in the OR or ambulatory surgical center for resection (tumor removal or Transurethral Resection of Bladder Tumor [TURBT]).
NBI has clinical applications throughout the anatomy including gastroenterology, pulmonary and rhinolaryngology (ENT), in addition to urology.
The company has received FDA approval for the screening and surveillance of Barrett’s esophagus, and is currently exploring other claims for NBI both in gynecology and general surgery.
Image: NBI has visualized NMIBC lesions in an additional 17% of patients, as compared to white light. Photo: courtesy of PRNewswire/ Olympus.