Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February.
A Chinese study has established a previously unknown direct mechanistic link between elevated mechanical tension caused by impaired alveolar regeneration and progressive idiopathic pulmonary fibrosis (IPF), highlighting a pathogenic mechanism that may underlie fibrosis.
KARACHI, Pakistan – Hit by international sanctions, medical device manufacturers in Iran now are looking to get their products out to the world with a little help from neighbor and friend Pakistan. This year, Iran’s med-tech makers have taken their first steps toward finding a new route for their products that goes beyond its neighbors.
Establishment Labs SA, from the Virgin Islands and with main manufacturing and marketing operations in Alajuela, Costa Rica, where it was founded, is entering the Japanese market with what it says is a revolutionary breast implant solution, starting this month.
HONG KONG – Boston-based consulting firm Analysis Group Inc. will be working with China’s Institute of Hematology & Blood Diseases Hospital (IHBDH) on developing a first-of-its-kind blood disease research platform. The National Longitudinal Cohort of Hematological Diseases in China (NICHE) is set to hold the information of more than 10,000 patients across China.
BEIJING – While acknowledging that China still needs to play catch up in med-tech innovation, Chinese cardiovascular experts are striving to make breakthroughs in bioabsorable stents and transcatheter heart valves with government-backed research projects underway.
BEIJING – Chinese transcatheter heart valve developer Venus Medtech (Hangzhou) Inc. on Tuesday saw its share prices jump around 20% on its debut on the Hong Kong Stock Exchange (HKEX), an excellent start for a prerevenue med-tech IPO.
PERTH, Australia – Industry was supportive of most of the changes proposed by Australia’s Therapeutic Goods Administration (TGA) for custom-made and 3D-printed devices. However, the comments also indicated that the current regulatory requirements for custom-made devices are not well understood. The agency stressed that increasing use of 3D printing for medical applications is raising questions about the adequacy of the current medical device regulatory framework to mitigate risks to patients.
BEIJING – Infection diagnostics specialist Genskey Technologies Co. Ltd., of Beijing, closed a series B financing round to secure ¥100 million (US$14 million) to advance pathogen testing using next generation sequencing. The series B round was joined by SB China Capital, Shanghai Lin Chong Investment Management, and Juyuan Capital.
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s traditional implant, the Osia implant bypasses damaged parts of the ear and sends sound vibrations directly to the cochlea.
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