The " Intra-Medullary Endo-Transilluminating device (iMET) " medical device developed by Professor Zhu Weiqin’s laboratory in the Department of Biomedical Engineering of our school was approved by the US FDA on February 17. 510(k) marketing license.
The image processing laboratory chaired by Professor Zhu Weiqin has been conducting research and development of medical equipment for the " Intra-Medullary Endo-Transilluminating Device " in 2010, and won the national plan of " Take-off Taiwan Biotechnology, Diamond Action" from 2010 to 2013. Granted, and received a subsidy from the Ministry of Science and Technology "Industry Foresight Technology" project in 2014; with the support and guidance of the "Taiwan Biotechnology Integration and Cultivation Center" (Si2C) and relevant units of the school, the prototype design of iMET Device was completed in mid-2015 With trial mass production, it has also successively applied for invention patents in seven countries: Taiwan, the United States, the European Union (England, Germany, France), China, and Japan (Note: The owner of the above patents is Yangming University).
iMET Device can accurately and quickly perform the "interlocking nailing procedure" surgical screw positioning without the need for external positioning devices or X-ray fluoroscopes. Since there is no additional radiation dose absorption, iMET Device can provide patients and medical staff performing operations with a safer and more effective medical environment and quality.
According to statistics, on average, every minute in Taiwan, one person sees a doctor with a fracture due to an accident. Among them, there are about 30,000 patients who have to be fixed with a device commonly known as intramedullary nails due to long bone fractures, compared with about 300,000 in the United States, and about 1.5 million intramedullary nail operation worldwide per year.
After market research and patent risk analysis, this product has market potential. Therefore, under the guidance of Si2C in mid-2015, "WeMED Biotech" was established and entered the Zhubei Biomedical Park at the same time.
The research and development of iMET Device has won many honorary awards, including: Times Foundation "2014 Biomedicine Agriculture Industry Competition" Potential Rookie Award; "2014 Taiwan Biotechnology Integration Incubating Center Si2C Three-in-Five Competition" Gold Award; Industrial Technology First place in the "2014 Science and Technology Innovation Capital Acceleration Plan Autumn Field Science and Technology Innovation Joint Announcement" held by the Research Institute Technology Innovation Club.
iMET products have passed various safety inspections, and filed in late 2016 to apply for the US FDA 510(k) Class II medical device marketing license; the application was submitted on February 17 this year (2017) Obtained FDA 510(k) marketing authorization (license number: K163037).
At present, we are actively discussing cooperation matters with domestic and foreign manufacturers or venture capital institutions, making preparations for mass production and listing of products, in order to open up opportunities for self-made high-end medical equipment made in Taiwan.
Other News
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Linking the Okinawa Biotech Industry (Prof. Woeichyn Chu, Founder of WeMED Biotech Inc.)
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Bio Asia Taipei 2019.
Photo taken with the President Guo of the National Yang Ming University (left)
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iMET demonstration, Encouraged by Taiwan’s President Tsai.