December

December 29, 2017

CFDA Approved In-Vitro Diagnostic (IVD) Reagents For Liver Cancer Detection

CFDA has just approved a prothrombin (DCP, PIVKA-II) and alpha-fetoprotein heterogeneity (AFP-L3) ratio of automatic chemiluminescence detection reagents, with China’s first fully independent owned intellectual property rights. This means that […]
December 27, 2017

Transenterix Forges a Local Partnership to Commercialize Its SurgiBot System in China

Transenterix, a US-based medical device company that builds surgical robotics to improve minimally invasive surgery, has announced that it has entered into an agreement with China’s Great Belief International Limited […]
December 26, 2017

Unidiag Completed Its Series A+ Round

Beijing Unidiag Technology Co., Ltd, a Chinese medical device and reagent developer, has raised 10M+ RMB in Series A+ round from National Small and Medium-size Enterprises Development Fund (Shenzhen Guozhong […]
December 23, 2017

CFDA Greenlighted A Treatment of Chronic Heart Failure in China

The Germany-based Impulse Dynamics just announced that China’s CFDA has approved its Optimizer® system for treatment of chronic heart failure.  Impulse Dynamics’ CEO, Dr. Simos Kedikoglou noted “this is a […]
December 22, 2017

Regulatory Affairs Event with CFDA Delegates a Success!

China Med Device and CABA held a quarterly Regulatory Affairs  event with CFDA representatives from Beijing in Cambridge, MA on Sunday, December 10. Nearly 50 Regulatory representatives from U.S. Medtech […]