Glaucoma involves sensitivity to ocular pressure (not just elevated pressure) that is translated or transduced to stress that degrades the optic nerve over time. Current glaucoma therapies lower pressure using eye drops, surgery, or both in order to reduce stress transduced to the optic nerve. This approach is effective for many patients. But for those who continue to lose vision, where should we turn for new clinical therapies? Continue reading “Research: Saving Sight in Glaucoma”
On October 25, 2016, The 5th WHO Interregional Seminar for Quality Control Laboratories involved in the WHO Prequalification was held in Shenzhen, Guangdong Province, China. It is the first time that the WHO seminar on prequalification of quality control laboratories was held in China. During the seminar, more than 60 laboratory directors from 42 countries and representatives from 26 provincial drug testing institutions of China had discussions on drug quality control, drug reference material development, analysis method study, quality control of drug testing laboratories, and exchanged experiences on laboratory management and certification. China Food and Drug Administration (CFDA) Vice Minister Sun Xianze, leaders of Shenzhen Municipal Government, relevant directors of the Department of Science, Technology and Standards of CFDA, National Institutes for Food and Drug Control, Guangdong Food and Drug Administration, and Food and Drug Administration of Shenzhen Municipality attended the seminar.
An official from the Department of Drug and Cosmetics Registration of CFDA was interviewed about “the issues on authenticity of clinical trial data in new drug registration applications” reported by media.
The official introduced that according to the Announcement on Performing Self-Examination & Verification of Drug Clinical Trial Data issued on July 22, 2015 by CFDA, for 1622 registration applications for marketing and import, the applicants had been required to do self-examination on the authenticity, integrity and compliance of clinical trial data. Deducting 193 registration applications exempted from clinical trial, the total number of applications for self-examination was 1429. Applicants could voluntarily withdraw their registration applications with problematic clinical trial and reapply after supplementing their dossiers. By the end of June, 2016, 1193 voluntary withdrawals happened after self-examination of the companies, accounting for 83% of the total number of registration applications for self-examination.
Continue reading “CFDA Official Explains the Verification of New Drug Clinical Trial Data”
Episurf Medical announced the public release of the Episealer surgical training simulation on the Touch Surgery app. The procedural simulation is now available to Touch Surgery’s audience of over 1.3 million users globally, which is a perfect match to the Episealer platform, a proprietary patient-specific approach to addressing knee lesions and previously untreatable joint pain problems.
Continue reading “Surgical training simulation on the Touch Surgery app released”
Baxter International Inc. announced the global launch of HDx enabled by THERANOVA, a new type of hemodialysis (HD) therapy that provides high performance treatments with integration into existing healthcare infrastructure. Baxter will launch HDx enabled by THERANOVA in Australia, New Zealand, France, Germany, Switzerland and Belgium this year.
Continue reading “Baxter Launches HDx Therapy to Provide High Performance Hemodialysis Treatments”
Clever Culture Systems AG (CCS), the Swiss based joint venture between Australian medical technology company LBT Innovations Limited and Hettich AG (Switzerland) has received clearance of its 510(k) de novo submission to the US Food and Drug Administration (FDA) for APAS® as a Class II medical device.
Continue reading “FDA approves AI powered Automated Plate Assessment System”