FujiFilm today announced it received FDA 510(k) clearance for its Scale Eye endoscopic imaging technology.
Scale Eye is part of the company’s expanding Eluxeo endoscopic imaging system. It has a laser-equipped colonoscope and endoscopy support software that displays linear or circular vital measurements or scales on an endoscopy monitor.
The company designed Scale Eye to help endoscopists estimate the size of colorectal lesions in vivo without relying on visual estimations, consumable tools or additional surgical instruments.
Typically, endoscopic estimate the size of neoplasms by comparing them against the size of the forceps being used to examine them, which creates the risk of subjectivity, according to FujiFilm. Scale Eye will help create more accurate and objective measurements of colon polyp size, which are critical factors in deciding how to manage neoplasms clinically.
“During colonoscopy, it is important to correctly measure the size of the polyps because it can directly impact the patient’s care pathway,” Tai Fujita, VP of endoscopy at Fujifilm Healthcare Americas, said in a news release. “Early clinical results of Scale Eye are impressive, and we’re proud that Fujifilm’s new, innovative in vivo scaling capability is demonstrating success in improving both the speed and accuracy of polyp measurement.”
FujiFilm reports that early results of Scale Eye show superiority compared to traditional open biopsy forceps. The accuracy rate when measuring with Scale Eye is 98.2% compared to 89% accuracy when measuring with forceps. The measurement time was also 2.8 seconds using Scale Eye compared to 8 seconds when measuring with forceps.
“When it comes to polyps, accurate size assessment is essential to our decision-making process. Polyp size is a factor in determining a patient’s recommended follow-up interval and may impact the decision on how best to achieve a safe and complete resection. We’re encouraged by early data and are excited to be the first U.S. site to evaluate Scale Eye,” said Dr. Seth Gross, clinical chief of the Department of Gastroenterology and Hepatology at NYU Langone Health.
The company plans to commercially launch Scale Eye in 2024 following the completion of a limited market evaluation.
