MILESTONES
Event
R&D
Management
2021
October
-Advanced AmCAD-UT with AI contouring function obtains FDA 510(k) approval
2020
December
-AmCAD-CA obtained Taiwan Excellence Award 2021
2019
December
-AmCAD-UO received the Gold Award of Drug Research and Development Science and Technology Award
-Received TFDA approval for AmCAD-UO
July
-AmCAD-UO awarded the annual Taiwan Bio-Industry Organization awards in Innovation of the Year category
January
-Received U.S. FDA 510(k) clearance for AmCAD-UO
2018
December
-AmCAD-UO obtained Taiwan Excellence Award 2019
October
-Received CE Marking approval for AmCAD-UO
2017
December
-AmCAD-UT awarded Taiwan Excellence Award 2018
July
-Received CFDA approval for AmCAD-UT Detection
May
-Received U.S. FDA 510(k) clearance for AmCAD-US
May
-Received U.S. FDA 510(k) clearance for AmCAD-UV
2016
December
-AmCAD-CA awarded the 13th National Innovation Award
-AmCAD-UT® Detection received the Gold Award of Drug Research and Development Science and Technology Award
July
-Received Frost & Sullivan Taiwan Business Best Practice Award
-Received Go-Global Silver Medal Award of Taipei Biotechnology Award
July
-Received TFDA clearance for upgrade version of AmCAD-UT® Detection
March
-Received CE Marking approval for AmCAD-UV
May
-Granted distribution right of China to Huajin Yike Pharmaceutical, based in Zhejiang Province, for AmCAD-UT® Detection with a US$5 million payment obligation
-Received CE Marking approval for AmCAD-US
2015
December
-Received Silver Award of National Biotechnology and Medical Care Quality Award for AmCAD-UT® Detection
March
-Listed on Taiwan’s OTC Stock Market (Code: 4188)
January
-Received TFDA clearance for AmCAD-UT® Detection
2014
May
-Received CE Marking approval for AmCAD-UT Detection 2.0
2013
December
-Listed on Taiwan’s Emerging Stock Market (Code: 4188)
December
-Recommended by Industrial Development Bureau (IDB), MoEA as a qualified technology enterprise for IPO application
October
-Received U.S. FDA 510(k) clearance for AmCAD-UT Detection 2.0
October
-Received Taiwan Healthcare and Agricultural Biotech Industries Innovation and Excellence Award
March
-Started to receive patent approvals for its core technologies in U.S., Singapore, Taiwan, etc
2012
March
-Awarded R&D project Grant, “Development of Calibration Method for Compatibility with Various US Machines”, by Taipei City Government
2011
December
-Received GMP certification for Software Manufacturing
May
-Received the “Certificate of Manufacturer of Medical Devices” after its factory establishment
2010
May
-Received The 7th National Innovation Award
2009
December
-Identified as a company of the emerging medical health care industry in Taiwan by Industrial Development Bureau (IDB)
July
-Awarded Industrial Technology Development Program (TDP) Grant “Computer-assisted thyroid disease ultrasound diagnostic system” by MoEA
July
-Received “Important Emerging Strategic Industry” status approval letter by Industrial Development Bureau(IDB) of Ministry of Economic Affairs(MoEA)
January
-Transferred technology with exclusive authorization from National Taiwan University.
2008
December
-AmCad BioMed Corporation(AmCad) was founded.