FDA clears Fujifilm endoscopic imaging system
Fujifilm Medical Systems, USA, Inc., announced this week that it has received 510 (k) clearance from the U.S. Food & Drug Administration (FDA) for its oxygen saturation endoscopic imaging system.
This system is designed to improve visualization for gastrointestinal, colorectal and advanced endoscopic and surgical procedures.
By allowing the visualization of the oxygen saturation of hemoglobin (StO2) in real time with laparoscopic and / or endoscopic images, said a company official, the system can help surgeons identify ischemic tissue. As a result, they could potentially prevent tissue necrosis.
“The prognosis is poor for tissue necrosis resulting from [gastrointestinal] procedural complications and reduced mortality rely on early detection and intervention, ”said Taisuke Fujita, vice president of Fujifilm’s endoscopy division. “As long-time leaders in endoscopic imaging, we are delighted to have evolved our image enhancement capabilities to address this deadly complication. “
This new system is an upgrade option for the ELUXEO® surgical system. It will add StO2 viewing mode with existing Blue Light Imaging, Linked Color Imaging® and White Light Endoscopy modes. Implementing this new mode can give surgeons even more unique information for better diagnoses during procedures.
This 510 (k) clearance follows Fujifilm’s achievement of the FDA Breakthrough Device designation six months ago for its endoscopic image enhancement technology.
According to company officials, the system will be available in the United States later this summer and globally later this year.