The FDA has given 510(k) clearance to a new endoscopy system with an on-screen scale.
The system, called Scale Eye (Fujifilm), which consists of a new endoscope (model EC-760S-A/L) and support software (model EW10-VM01) and is part of Fujifilm’s Eluxedo Endoscopic Imaging System, displays a linear or circular scale on screen that endoscopists can use to measure polyps, lesions or any area of interest. To use the scale, endoscopists can position a laser to the left edge of the objects they want to measure. The position of the laser changes based on the distance between the object and the endoscope’s tip.
The FDA clearance follows positive results presented at UEG Week 2022 that revealed the scale measured with an accuracy rate of 98.2%, versus an 89% accuracy rate found with forceps. In addition to improving accuracy, the virtual scale was associated with a reduced measurement time of 2.8 seconds, versus 8 seconds using forceps.
The new system enables more accurate measuring during endoscopy, according to Seth Gross, MD, the clinical chief of the Department of Gastroenterology and Hepatology at NYU Langone Health, in New York City. “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," Dr. Gross noted in a Fujifilm press release. He said he and his colleagues are "encouraged by early data" they've seen at their center, "the first U.S. site to evaluate Scale Eye.”
The company said the system will be available for purchase later in 2024 following a limited market evaluation to assess user clinical feedback and economic considerations.
—GEN Staff
Based on a Fujifilm press release.
Dr. Gross is a member of the Gastroenterology & Endoscopy News editorial board.
