{"id":"AIBD-1161","title":"Japan's health ministry recognizes that EndoBRAIN-EYE raises specialists' colonoscopy accuracy and makes it eligible for an insurance add-on","summary":"Japan's health ministry recognized EndoBRAIN-EYE as shown to raise specialists' diagnostic accuracy in colonoscopy, which made it eligible for a new insurance add-on to polyp removal.","date_observed":"2024-03-28","date_basis":"source publication","date_precision":"day","benefit_status":"reported","source_collection":null,"source_entry":null,"account":"Cybernet Systems built EndoBRAIN-EYE with Showa University Northern Yokohama Hospital and Nagoya University. The program uses AI to analyze colonoscopy images in real time and help doctors detect polyps and other lesions. It was approved in Japan in 2020 and first covered by insurance with no extra fee. For the fiscal 2024 revision, the Ministry of Health, Labour and Welfare created an add-on to the fee for colonoscopic polyp removal (K721). It applies to detection programs recognized as raising the diagnostic accuracy of colonoscopy specialists, compared with not using them. In an official Q&A dated 28 March 2024, the ministry stated that EndoBRAIN-EYE is at present such a product. A trade journal reported on 19 April 2024 that the evaluation behind the add-on rested on a rise in specialists' tumor detection rate from 21.6% to 31.2%. It reported that the add-on is worth 60 points. The ministry's Q&A gives no figures and names no study. The revised fees took effect on 1 June 2024.","category":"aggregate result","unexpected":false,"purpose":"Cybernet Systems built EndoBRAIN-EYE to analyze colonoscopy images in real time and help doctors detect polyps and other colorectal lesions.","system":"EndoBRAIN-EYE (内視鏡画像診断支援プログラム)","model_version":null,"developer":"Cybernet Systems Co., Ltd. (サイバネットシステム株式会社), with Showa University Northern Yokohama Hospital and Nagoya University","deployer":"Japanese hospitals and clinics where colonoscopy specialists use it during polyp removal (not named)","location":"Japan","domain":"Healthcare","segment":null,"benefit_type":"Improved Task Accuracy","work_activities":["4.A.1.b.1","4.A.1.a.2"],"taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"personal","depth":2,"reason":"The ministry recognized higher diagnostic accuracy for specialists using the program, and a trade journal reported a rise in their tumor detection rate from 21.6% to 31.2%."}],"ai_role":{"status":"assessed","statement":"The ministry recognized the program as raising specialists' diagnostic accuracy compared with not using it, a comparison with and without the program. The Q&A gives no figures and names no study. It describes software that analyzes colonoscopy video, and PMDA lists EndoBRAIN-EYE among approved AI-based programs."},"evidence":[{"kind":"assessment report","citation":"Ministry of Health, Labour and Welfare (MHLW), Health Insurance Bureau, Medical Economics Division, Japan. 疑義解釈資料の送付について（その１）(Q&A on the interpretation of the fiscal 2024 medical fee schedule, part 1), office communication of 28 March 2024. Attachment 1 (medical fee schedule), Question 221, p. 医-58.","title":"疑義解釈資料の送付について（その１）","url":"https://www.mhlw.go.jp/content/12404000/001237675.pdf","date":"2024-03-28","written_by":"independent","quote":"用いない場合と比較して診断精度が上昇することが示されていると認められた製品」は何が含まれるか。（答）現時点では、｢内視鏡画像診断支援プログラム EndoBRAIN-EYE（医療機器承認番号 30200BZX0020800）｣が含まれる。"},{"kind":"news report","citation":"Web医事新報 (Japan Medical Journal). 大腸内視鏡診断支援AI「EndoBRAIN-EYE」が保険収載（サイバネット）(Colonoscopy diagnosis-support AI EndoBRAIN-EYE listed for insurance (Cybernet)), Close-up Health Tech column. Posted 19 April 2024.","title":"大腸内視鏡診断支援AI「EndoBRAIN-EYE」が保険収載（サイバネット）［クローズアップHealth Tech］","url":"https://www.jmedj.co.jp/blogs/product/product_24151","date":"2024-04-19","written_by":"independent","quote":"本製品を使用することで専門医の腫瘍検出率が21.6％から31.2％に診断精度が上昇することが評価され「区分C2（新機能・新技術）」で、内視鏡的大腸ポリープ・粘膜切除術において、病変検出を支援するプログラム医療機器を用いて実施した場合の加算として、60点が付くこととなった。"},{"kind":"regulatory document","citation":"Pharmaceuticals and Medical Devices Agency (PMDA), Japan. 資料２, PMDA提出資料, 第22回 医療機器・体外診断薬の承認審査や安全対策等に関する定期意見交換会 (Document 2, submitted by PMDA to the 22nd regular exchange meeting on the review and safety of medical devices and in vitro diagnostics), 7 October 2024. Table AIを活用した医療機器（プログラム）の承認状況（R6.9末現在） (approval status of AI-based program devices as of the end of September 2024).","title":"第22回 医療機器・体外診断薬の承認審査や安全対策等に関する定期意見交換会 PMDA提出資料","url":"https://www.mhlw.go.jp/content/11124500/001329696.pdf","date":"2024-10-07","written_by":"independent","quote":"EndoBRAIN-EYE サイバネットシステム株式会社 内視鏡画像から大腸ポリープ病変の存在の検出支援","supports_benefit":false}],"replication":{"produced_by":["The program analyzed colonoscopy video to detect the features of colorectal polyps and support their detection.","Doctors with specialist knowledge and experience in colonoscopy used it during colonoscopic polyp and mucosal resection."],"must_hold":["A doctor with specialist knowledge and experience in colonoscopy performs the procedure.","The program is one that the ministry recognizes as raising diagnostic accuracy compared with not using it."],"echoes":[]},"paired_incident":null,"headline":"*EndoBRAIN-EYE* wins a Japanese insurance add-on for better colonoscopy","metric":"tumor detection rate from 21.6% to 31.2%","comparator":{"against":"Colonoscopy by specialists without the program","before":"21.6％ tumor detection rate","after":"31.2％ tumor detection rate","basis":"measured","quote":"本製品を使用することで専門医の腫瘍検出率が21.6％から31.2％に診断精度が上昇することが評価され「区分C2（新機能・新技術）」で、内視鏡的大腸ポリープ・粘膜切除術において、病変検出を支援するプログラム医療機器を用いて実施した場合の加算として、60点が付くこととなった。","url":"https://www.jmedj.co.jp/blogs/product/product_24151"},"later":null,"value":null,"developer_country":"Japan","deployer_country":"Japan","unrated_because":null,"brief_notes":null,"brief":null,"revisions":[{"date":"2026-11-01","change":"Added the record from the finding of Japan's Ministry of Health, Labour and Welfare (MHLW).","source":"https://www.mhlw.go.jp/content/12404000/001237675.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by an assessment body","claim_basis":"Sources: one independent regulatory document, one independent assessment report and one independent news report. 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