• [2021.03.24] EOPatch’s Smartphone Application 'Narsha' gets Korean MFDS Approval

    Mar.24.2021
  • 210324 EOFlow EOPatch Smartphone Application 'Narsha' gets Korean MFDS Approval_FN.pdf (58,996k)
  • ▶ World's first commercialized smartphone app to delivery insulin for wearable pump
    ▶ Satisfied the cyber security requirements from the Korean MFDS and market needs
    ▶ EOFlow's first wearable insulin pump, EOPatch will be fully launched in Korea on the 29th


    On March 24, EOFlow, a provider of wearable drug delivery solutions, has announced on the 24th that ‘Narsha,’ a smartphone application for wearable insulin delivery, obtained medical device approval from the Ministry of Food and Drug Safety (MFDS) on the 23rd.
     
    Narsha is a smartphone application(hereinafter referred to as an app) that can monitor the device and control insulin injection of a tubless, wearable ‘EOPatch’. Narsha is known to be the world's first app that can control insulin injection from a wearable pump. Narsha also integrates separate continuous glucose monitoring sensor(CGMS) and a user can also monitor their blood glucose level. Dexcom's G6 is currently available.
     
    The existing EOPatch insulin management system consists of a wearable insulin pump ‘The Patch,’ a smartphone like controller ‘ADM,’ and a diabetes management software ‘EOBridge.' Patches and ADMs control insulin injections and the injection history is stored up to 90 days. Data is synced to the EOBridge app or web to be analyzed and can be shared with guardians or medical personnel.
    Even though ADM is a convenient, portable smartphone like device, there was a great need for an app development.
     
    EOFlow official said, "We expect Narsha app will greatly improve user convenience by eliminating the need to carry separate controller. Also, Narsha has more advanced screen design which brings improved usability."
     
    Cyber security is essential when devices like ADM or Narsha app which is connected to an insulin injector via bluetooth. If the device is vulnerable to security, there is a cyber security threat, it is hacked and causes malfunction, personal medical information may leak and the user's health may be severely affected by an error in insulin injection.
     
    "Narsha has met all the cyber security requirements of a medical device set by the Korean Ministry of Food and Drug Safety," an Eoflow official said. "In addition, there is no large cost to download an app from an app store, so it is very economical, and high demand in the market is expected.”
     
    EOFlow plans to fully launch its first wearable insulin pump, EOPatch in Korea on March 29th. The full launch will be with ADM, a separate controller. Narsha app will be released in about two months after user manuals and educational materials are prepared.

    ▣ For all Investment and Press Inquiries, please contact ir.pr@eoflow.com

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