AmCad BioMed Corp (AmCad, 安克生醫), a subsidiary of PhytoHealth Corp (懷特生技), yesterday said it has obtained a license in Taiwan for software it has designed to aid physicians diagnose thyroid problems.
It is the first time the Food and Drug Administration has granted a license to locally developed computer-aided design (CAD) software, the Taipei-based firm said.
The software won clearance in 2013 to be marketed in the US and last year in Europe, AmCad said.
“The license marks yet another milestone for AmCad, suggesting that the company has won access to the world’s three largest markets — the US, Europe and China,” AmCad general manager Chen Cheng-kang (陳正剛) said.
The license in Taiwan is equivalent to acquiring a license in China, the company said.
The software — based on technology initially developed by National Taiwan University (NTU) and NTU Hospital — uses statistical pattern recognition and quantification methods on data provided by sonography to process images, the firm said.
The software provides more detailed information with quantification and visualization of sonographic characteristics on thyroid nodules and enables physicians to make diagnoses without the aid of invasive procedures, the company said.
The achievement makes AmCad a world leader in the development of CAD software for ultrasound images of thyroid nodules.
C.C. Lee (李成家), chairman of Maywufa Co (美吾華), which owns PhytoHealth Corp, a drugstore chain and other businesses, said the group has set up a sales team to promote the software among local hospitals and medical testing facilities, as well as abroad.
AmCad is listed on the Emerging Stock Market and plans to list in the over-the-counter GRETAI Securities Market in late March, the company said.
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