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2019 / Nov. 13

MEDIA COVERAGE

「米国FDAからブレイクスルーデバイスの指定」に関して、複数のメディアに掲載されました

開発中の内視鏡画像診断支援AI(人工知能)システムが、米国食品医薬品局(FDA)よりブレイクスルーデバイス指定(画期的医療機器/デバイス指定)を受けた事に関して、複数のメディアに取り上げられました。

・日経メディカル
日本発の胃内視鏡用診断補助AI、世界へ羽ばたく
https://medical.nikkeibp.co.jp/leaf/mem/pub/report/201911/562959.html

・m3.com
日本人医師開発の胃癌内視鏡診断支援AI、FDAからブレイクスルー・デバイス指定に
https://medicalai.m3.com/open/news/191107-news-aim?pagefrom=fb_ai

・MedCity News, Arundhati Parmar
Japanese firm’s AI algorithm for gastric cancer gets FDA’s Breakthrough Device designation
https://medcitynews.com/2019/11/japanese-firms-ai-algorithm-for-gastric-cancer-gets-fdas-breakthrough-device-deisgnation/

・Inside Digital Health, Samara Rosenfeld
AI Endoscopy Tech Receives FDA Breakthrough Device Designation
https://www.idigitalhealth.com/news/ai-endoscopy-tech-receives-fda-breakthrough-device-designation

・HIT Consultant, Fred Pennic
Japanese Startup AI Medical Secures FDA Approval for Real-Time Endoscopic AI Platform
https://hitconsultant.net/2019/11/11/ai-medical-secures-fda-approval-for-real-time-endoscopic-ai-platform/#.XcoFK5IzbOR

・AiThority, News Desk
AI Medical Service INC. Announces FDA Breakthrough Device Designation for Endoscopic AI System
https://www.aithority.com/technology/ai-medical-service-inc-announces-fda-breakthrough-device-designation-for-endoscopic-ai-system/

・Regulatory Affairs Professionals Society, Michael Mezher
Recon: FDA Rejects Lipocine Testosterone Drug for the Third Time; Roche SMA Drug Hits Goal in Pivotal Study
https://www.raps.org/news-and-articles/news-articles/2019/11/recon-fda-rejects-lipocine-testosterone-drug-for

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