Insung u-Health Device Approved by KFDA
-HiCare Dr-U approved by KFDA as a mobile multi-function medical monitoring device
-The manufacturer also prepares for CE and FDA approvals
March 30, 2010, SEOUL
Insung Information (www.insunginfo.co.kr) announced today that the company’s HiCare Dr-U (“Doctor You”) MX-554 has been approved by KFDA (Korea Food and Drug Administration) as a “multi-function medical monitoring device.” HiCare Dr-U is the first device of its kind to get a KFDA approval.
The device is also the world’s first multi-function medical monitoring device that supports mobile environment.
HiCare Dr-U MX-554 is a ubiquitous healthcare device, providing patients with real-time accesses to remote health monitoring services regardless of time and location. The device monitors various vital readings (such as blood pressure, glucose level, pulse, 12Ch ECG, oxygen saturation, body temperature, etc.) and transmits the data in real-time to the service server, which then analyzes the data and returns feedback on the patient’s health status and necessary actions for any abnormalities or emergencies.
Connected to information systems (EMR, OCS, PACS) at a healthcare provider (such as a hospital), the device can also access the healthcare provider database for the patient’s history, allowing the patient to receive a full healthcare service without a hospital visit.
The device supports various communications technologies (Serial, Bluetooth, Wireless, CDMA, and GSM) to connect to a network for data exchange with external systems.
HiCare Dr-U MX-554 is especially useful for patients who are immobile or in a remote area with limited access to healthcare facilities. These patients can benefit from using the device for constant health monitoring at home, with the help from healthcare providers visiting their homes (such as nurses) when necessary.
Another notable feature of HiCare Dr-U MX-554 is integration with Insung Information’s HiCare service server, which provides high-quality u-healthcare services including access to healthcare content and real-time feedback on health monitoring.
HiCare Dr-U MX-554 is the only mobile health monitoring device approved by KFDA to this date. When the new law regarding remote healthcare services takes effects this year, the device will be in high demand as the point-of-care monitoring device for remote healthcare services such as home-visit healthcare and emergency care.
The new law enforces use of KFDA-approved devices, healthcare providers must employ such devices to comply with the law governing u-healthcare services.
From now on, El Bio, an Insung affiliate, will be responsible for manufacturing the device, and Insung Information will take charge of sales under its u-healthcare brand, HiCare.
Mr. Jong-Yoon Won, CEO of Insung Information, comments that “KFDA approval on HiCare Dr-U MX-554 is an important opportunity for the company, especially with the new u-healthcare law to take effects this year. We will also focus on promoting the device in the global market, as soon as it gets CE marking and FDA approval.”
The prospective target market for HiCare Dr-U MX-554 includes Northern Europe, China, and Vietnam. Insung Information is expecting the KFDA approval on the device will provide leverage for its business in the global market, as well as in Korea.