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Press release
2019年01月11日 11時00分
Source:
Honda Motor Co, Ltd
「Honda歩行アシスト」が米国で医療機器の認証を取得
東京, 2019年01月11日 - (JCN Newswire) - Hondaの歩行訓練機器「Honda歩行アシスト」※が、米国・食品医薬品局（FDA：the U.S. Food and Drug Administration）の市販前承認（PMA：Premarket Approval）を2018年12月に取得しました。これにより米国において、Honda歩行アシストの技術的な実証実験だけでなく、事業展開が可能になります。
医療機器に該当する製品を国内外の製造業者が米国で販売するためには、日本の厚生労働省にあたる米国・保健福祉省（HHS：Department of Health and Human Services）が所管する連邦政府機関のFDAから承認を取得する必要があります。
米国では、2014年にリハビリテーション施設であるシャーリー・ライアン・アビリティー研究所（SRAL：Shirley Ryan AbilityLab）とHonda歩行アシストの有効性に関する実証実験を行いました。それらの成果は、今回のFDAによる市販前承認の取得にもつながっています。
今回の医療機器認証の取得は、欧州の医療機器指令（MDD：Medical Device Directive / CEマーキング）に次ぐもので、Honda歩行アシストの安全性や機能が米国においても認められたことになります。
Hondaは、1999年に歩行アシストの研究を開始し、2015年11月より日本国内の法人様向けに歩行訓練機器としてリース販売を行っており、全国の約250の施設で歩行訓練や歩行能力の計測などにご利用いただいています。
本リリースの詳細は下記をご参照ください。
https://www.honda.co.jp/news/2019/c190111a.html
概要：本田技研工業株式会社
詳細は www.honda.co.jp をご覧ください。
Source: Honda Motor Co, Ltd
セクター: 自動車, ビジネス, エンジニアリング
Copyright ©2026 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
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