Fujifilm SCALE EYE measures colonic lesions

28 Feb 2024

Endoscopic imaging platform receives 510(k) clearance and moves towards market.

Fujifilm Healthcare has been granted FDA 510(k) clearance for its SCALE EYE imaging system, as the device moves towards market availability.

Consisting of a laser-equipped colonoscope and endoscopy support software, the SCALE EYE system is designed to help endoscopists in estimating the size of colorectal lesions in vivo without relying on subjective visual estimations or additional surgical instruments.

"During colonoscopy, it is important to correctly measure the size of the polyps because it can directly impact the patient’s care pathway," said Tai Fujita of Fujifilm Healthcare Endoscopy Division.

"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."

Endoscopists traditionally estimate the size of colonic lesions and neoplasms by comparing them against the size of the forceps being used to examine them, which introduces an unwelcome subjective element.

An optical method of carrying out the measurement should enable more accurate and objective measurement of colon polyp size, a critical factor in then making decisions for clinical management. The size of the polyp can be an indicator of malignancy and have implications for risk stratification and choice of polypectomy technique.

In the SCALE EYE platform, a Class 1 laser is incorporated into the device with its illumination point visible within the endoscopic image. Fujifilm's bespoke "virtual scale" software detects the position of the laser point and monitors the distance from the tissue, and presents an appropriate virtual scale on the right side of the image to the endoscopist.

Objective and faster to guide clinical procedures

As the position of the illumination point changes relative to the tissues being examined, the measurement scale shown in the image adjusts automatically between 5, 10 and 20 millimeters, giving the operator a consistent assessment of the size of the lesion being examined.

Trials using the SCALE EYE device have indicated the advantages of such a virtual scale endoscope (VSE) compared to the traditional open forceps measurements, according to Fujifilm Healthcare.

SCALE EYE product data indicates that the accuracy rate when measuring with the VSE instrument is 98.2 percent, compared to 89 percent accuracy rate when measuring with forceps. Measurement time was drastically shorter, 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," commented Seth Gross, clinical chief of the Department of Gastroenterology and Hepatology at NYU Langone Health. "We're encouraged by early data and are excited to be the first US site to evaluate SCALE EYE."