FDA approves Fujifilm AI endoscopy technology that could compete with Medtronic’s GI Genius

A Fujifilm AI Endoscopy powered detection system for endoscopic imaging was recently cleared by the FDA under the 510(k) regulatory pathway.

Fujifilm AI Endoscopy CAD EYE System

Through CAD EYE, colonic mucosal lesions can be detected in real time during colonoscopy, including polyps and adenomas. It assists endoscopists in identifying and removing pre-cancerous lesions, no matter their size, shape, or color. This system is entering a market dominated by Medtronic’s GI Genius.

The Fujifilm AI endoscopy support software (EW10-EC02) are compatible with Fujifilm’s computer-aided polyp detection system. The system was introduced in the U.S. in 2021. With AI image processing for integration with the processor and endoscope, CAD Eye builds on the company’s Eluxeo endoscopic imaging system.

As soon as the company completes a limited market evaluation, CAD EYE will become commercially available.

It is our mission every day to provide endoscopists with the tools they need to combat this public health issue by providing them with what we consider to be the highest quality imaging and optics, according to Tai Fujita, GM for Fujifilm Healthcare Americas Corporation. As a result of CAD EYE, we are thrilled to take that step further to dramatically improve colonoscopy quality.”

Here is more information about Fujifilm CAD EYE System

CAD EYE was developed by Fujifilm with deep learning technology in its Tokyo-based global AI technology center. Histological confirmation of polyps in clinical images was used to validate the system.

The CAD EYE uses white light imaging as well as Linked Color Imaging (LCI). Fujifilm includes enhanced visualization mode that enhances the mucosal visualization through the differentiation of the red color spectrum.

The technology, according to the news release, can be used to detect lesions that may be easy to miss. CAD EYE identifies suspicious polyps, and the physician receives visual and auditory alerts automatically. It is possible to detect flat, cornered, and multiple lesions within a single frame. Visual cues overlay the clinical images, but do not interfere.

Studies have shown that CAD EYE can lead to significant improvements in the diagnosis and detection of colorectal cancer. In comparison to conventional high-definition colonoscopy without AI assistance, the system detects significantly more adenomas during screening and surveillance. And, the procedure time does not increase.

In addition, Fujifilm has observed a 17% increase in adenoma per colonoscopy when compared with high-definition conventional colonoscopy. The system detects colorectal neoplastic lesions as accurately as an expert while better than a beginner, the company claims.

I am heartened by Fujifilm AI Endoscopy CAD polyp detection algorithm’s FDA approval as a gastroenterologist dedicated to patient safety and care. As a result of this breakthrough, not only can colorectal cancer be detected early, but missed lesions will also be significantly reduced, enhancing precision and improving patient outcomes,” DR. Sravanthi Parasa from the Swedish Medical Center said.

We are committed to embracing technological innovations to safeguard patients’ health, and this marks a pivotal advancement in our capabilities.”