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New App for Hypertension Treatment Receives Regulatory Approval

CureApp, an application for the treatment of hypertension, received approval from the Ministry of Health, Labor, and Welfare (MHLW) on March 9^th, the company announced on its website.

CureApp aims to support lifestyle improvement and its effectiveness was reported at the European Society of Cardiology Congress (ESC 2021) by Dr. Nanaomi Kario of the Department of Cardiology, Jichi Medical University. The HERB - DH1 trial, which evaluated the effectiveness of the application, included 390 essential hypertension patients from 12 facilities in Japan who were not using antihypertensive drugs or had not taken them for more than 3 months, and showed that the use of the app provided favorable therapeutic effects. The company had applied to the MHLW for regulatory approval based on the results of this trial.

With the revision of medical fees FY 2022, it has been decided that a new item will be established for "additional medical management for programmed medical devices," and with this approval, the system is now in place for apps to be used in the medical field. This is the first pharmaceutical approval from the MHLW of a "stand-alone software application for therapeutic use," and is expected to lead to a series of further therapeutic apps being developed in this area.

Until now, the standard of care has been lifestyle modification, drugs, and intervention by healthcare professionals, but the time has come to integrate software in order to provide digital treatment to patients on an individual basis.

※コンテンツには、国内で未承認、適応外の医療機器、医薬品、または効能・効果/用法・用量の情報を含む場合がありますが、未承認、適応外の使用を推奨するものではありません。

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