The FDA has granted 510(k) clearance to a new artificial intelligence program (CAD EYE, Fujifilm) to aid in detection of polyps during endoscopy.
The program, which includes an expansion unit (Fujifilm EX-1) and support software (EW10-EC02), pairs with the Fujifilm Eluxeo endoscopic imaging system to highlight lesions that may be missed, such as flat lesions or ones at the end of the frame of view, according to the company. When the software detects a suspicious polyp, visual alerts appear on screen on top of the clinical images—specifically a detection box and visual assist circle—and an auditory alert sounds to notify the endoscopists. The company notes that the alerts can be changed to meet each clinician’s preferences.
The system can be used during two imaging modes—white light imaging and linked color imaging, an enhanced visualization mode—and endoscopists can launch the system via buttons on the endoscope handle or processor unit.
Previous studies support CAD EYE’s use in aiding endoscopists in polyp detection. A recent randomized controlled trial using the software found that its use increased adenoma per colonoscopy (APC) rates over those seen with colonoscopy without the software (0.99±1.6 vs. 0.85±1.5; P=0.02) (Am J Gastroenterol 2024 Feb 23. doi:10.14309/ajg.0000000000002664). Other research found increased APC and adenoma detection rates when endoscopists used the software (Endoscopy 2022;54[12]:1171-1179), and further randomized controlled trials have supported the use of AI in endoscopy.
The company expects CAD EYE to be available for purchase later this spring after it completes a limited market evaluation.
—GEN Staff
Based on a Fujifilm press release.
