Fujifilm Healthcare Americas Corp. has nabbed U.S. FDA 510(k) clearance for Scale Eye, a new endoscopic imaging technology integrated into its Eluxeo endoscopic imaging system. Scale Eye comprises a laser-equipped colonoscope (model EC-760S-A/L) and endoscopy support software (EW10-VM01), with a virtual measurement scale on the monitor for precise area measurement.

Moreover, Scale Eye assists endoscopists in quickly estimating the size of colorectal lesions in vivo without the need for visual estimations, consumable tools, or additional surgical instruments, accessible with a press of a button.

Endoscopists traditionally estimate neoplasm size by comparing it to the forceps used for examination, leading to subjective risk. Scale Eye provides a more precise and objective method for measuring colon polyp size compared to the biopsy forceps approach. This accuracy is vital for clinical decisions regarding neoplasms, particularly colonic polyps, where size can indicate malignancy. Accurate polyp size measurements inform risk assessment, polypectomy technique selection, and follow-up interval decisions.

“During colonoscopy, it is important to correctly measure the size of the polyps because it can directly impact the patient’s care pathway,” says Tai Fujita, Fujifilm’s vice president of endoscopy. “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.”

Early results of Fujifilm’s Scale Eye have shown:

  • The accuracy rate when measuring with Scale Eye is 98.2%, compared to 89% accuracy rate when measuring with forceps.
  • Measurement time was 2.8 seconds using Scale Eye, compared to 8 seconds when measuring with forceps.
  • Visual measurement overestimated polyp size in 57.3% of cases.
  • The virtual scale function allows for standardization of measurement from endoscopist to endoscopist.

“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,” says Seth Gross, MD, clinical chief of the department of gastroenterology and hepatology, NYU Langone Health.”