HONG KONG – Los Angeles-based medical device accelerator Medtech Innovator and Asia Pacific Medical Technology Association (APACMed) have picked five finalists to compete for the title of the 2020 Asia Pacific Grand Prize winner, out of more than 170 applicants. Cartosense, Healthy Networks, Remidio, Sporogenics, and X-Zell were selected for the Medtech Innovator Asia Pacific competition, now in its second year.
PERTH, Australia – Gbs Inc. reported filing an initial public offering on the Nasdaq for $20 million, as the company looks to launch the first noninvasive SARS-Cov-2 test. A subsidiary of Sydney-based The Iq Group Ltd. (NSX:IQG), Delaware-based Gbs has developed a biosensor platform that enables real-time diagnostic point-of-care (POC) tests, and the funds raised will enable the company to launch its SARS- CoV-2 test and a saliva glucose test.
Taiwan’s FDA rolled out two new supplementary regulations on periodic safety updates and adverse event notifications for medical devices in October. They are part of its Medical Device Management Law that was reported on Jan. 15. As Taiwan is stepping up innovation of and regulation for medical devices, the nation for the first time decided to separate the regulation of medical devices from pharmaceutical products.
HONG KONG – Aprinoia Therapeutics Inc. is poised to start phase III clinical trials for its positron emission tomography (PET) imaging tracer 18F-APN-1607 in China, after receiving the green light from the National Medical Products Administration.
PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has linked up with Hong Kong-listed China Grand Pharmaceutical and Healthcare Holdings Ltd. (CGP) in a licensing and commercial deal worth AU$400 million (US$285 million) plus sales royalties.
Ocular Therapeutix Inc. and Affamed Therapeutics Ltd. entered a license and collaboration agreement to develop and commercialize Dextenza and OTX-TIC in greater China, South Korea and the Association of Southeast Asian Nations markets.
HONG KONG – Kangstem Biotech Co. Ltd. has completed research on South Korea’s first artificial liver and is taking the next steps towards the device’s clinical trials.
PERTH, Australia – Neuroscience technology company Cogstate Ltd. and Japanese pharmaceutical company Eisai Co. Ltd. signed a deal under which Eisai will have global development rights and exclusive commercialization rights of all cognitive function tests developed by Cogstate, including the Cogstate Brief Battery (CBB) for use in health care and other markets.
The Chinatrials roundtable went virtual this year and drew clinical trial experts to discuss state-of-the-art clinical trial design strategies, which are increasingly important in a more competitive clinical landscape.
PERTH, Australia – See-Mode Technologies has received 510(k) clearance from the U.S. FDA to market its Augmented Vascular Analysis (AVA) program that uses artificial intelligence (AI) to analyze vascular ultrasound scans to better predict stroke. Caused by plaque that ruptures in blood vessels and blocks blood flow to the brain, stroke affects roughly 15 million people per year and is the second-leading cause of death globally.