Artificial intelligence in gastroenterology practice: Current perspectives and emerging prospects

Table 9 Artificial intelligence systems approved for clinical use in gastroenterology

AI system name	Company	Clinical use	Regulatory authority ID
Japan - PMDA/MHLW
EndoBRAIN	Cybernet Systems Ltd.	CADx for differentiating neoplastic and non-neoplastic colorectal lesions using magnified endoscopy	PMDA: 23000BZX00372000
EndoBRAIN-EYE	Cybernet Systems Ltd.	CADe for detecting colorectal lesions during colonoscopy	PMDA: 30200BZX00208000
EndoBRAIN-UC	Cybernet Systems Ltd.	AI-assisted assessment of inflammatory activity in UC	PMDA: 30200BZX00136000
EndoBRAIN-Plus	Cybernet Systems Ltd.	CADx for predicting histological category of colorectal lesions	PMDA: 30200BZX00235000
CAD EYE (EW10-EC02)	Fujifilm Corporation	CADe/CADx for colorectal lesion detection and neoplastic/non-neoplastic differentiation	PMDA: 30200BZX00288000
CAD EYE (EW10-EG01)	Fujifilm Corporation	CADe for suspected esophageal squamous cell carcinoma and gastric neoplastic lesions	PMDA: 30400BZX00217000
EIRL Colon Polyp	LPIXEL Inc.	CADe for detecting colorectal polyps	PMDA: 30400BZX00259000
EndoBRAIN-X	Cybernet Systems Ltd.	CADx for differentiating colorectal neoplastic and non-neoplastic lesions using NBI	PMDA: 30500BZX00007000
gastroAI model-G2	AI Medical Service Co., Ltd.	CADe for detecting suspicious areas for early gastric cancer and adenoma	PMDA: 30600BZX00266000
United States-FDA
GI Genius™	Cosmo Artificial Intelligence - AI Ltd.	AI-assisted real-time detection of colorectal polyps and other mucosal lesions	FDA: K241887
EndoScreener	Chengdu Wision Medical Device Co., Ltd.	AI-assisted real-time detection of colorectal polyps	FDA: K211326
SKOUT® system	Iterative Health	AI-assisted real-time detection and localization of colorectal polyps	FDA: K253664
CAD EYE (EW10-EC02)	Fujifilm Corporation	AI-assisted detection of colorectal lesion candidates	FDA: K230751
NaviCam ProScan	Ankon Technologies Co., Ltd.	AI-assisted analysis of CE images for GI lesion detection	FDA: DEN230027
MAGENTIQ-COLO	Magentiq Eye Ltd.	CADe for real-time detection of colorectal lesions	FDA: K252178
CADDIE	Odin Medical Limited	AI-assisted detection of suspected colorectal polyps	FDA: K252586
Gastric Alimetry	Alimetry Ltd.	Analysis of gastric myoelectrical activity to aid diagnosis of gastric disorders	FDA: K252504
Deep Capsule®	Digestaid - Artificial Intelligence Development SA	AI-assisted analysis of CE videos for GI lesion detection	FDA: K250655
European Union - EUDAMED/EU MDR
CADDIE	Odin Medical Limited	AI-assisted detection of colorectal polyps	Basic UDI-DI: B-15065010840000
CADU	Odin Medical Limited	AI-assisted detection/characterization of dysplasia in Barrett’s esophagus	Basic UDI-DI: B-15065010840017
SMARTIBD	Odin Medical Limited	AI-assisted assessment of inflammatory activity in UC during colonoscopy	Basic UDI-DI: 5065010840OD04PF
GI Genius™ software	LINKVERSE S.R.L.	AI-assisted real-time detection of colorectal polyps	Basic UDI-DI: 8055060115WDCBB

AI: Artificial intelligence; CADe: Computer-aided detection; CADx: Computer-aided diagnosis; CE: Capsule endoscopy; EUDAMED: European Database on Medical Devices; EU MDR: European Union Medical Device Regulation; FDA: Food and Drug Administration; GI: Gastrointestinal; ID: Identification; MHLW: Ministry of Health, Labour and Welfare; NBI: Narrow-band imaging; PMDA: Pharmaceuticals and Medical Devices Agency; UC: Ulcerative colitis; UDI-DI: Unique device identifier-device identifier.