China’s NMPA has approved 12 antigen self-test kits between March 12 and 16 amid COVID-19 outbreaks in many parts of the country. The regulator claims that there will soon be more test kits approved. The number of COVID-19 infectious cases in China surged rapidly over the first half of March.
By using roughly 400 data points, from molecular to physical fitness, researchers have gained new insights into how organs such as the heart vs. the skin, and systems such as the immune and metabolic systems, age at different rates within individuals.
Neuton Health Co. Ltd.’s virtual reality (VR)-based therapy for acrophobia has been given class II medical device approval from China’s NMPA. The VR therapy, known as Specific Fear Rehabilitation Training Software, was co-developed with the Shanghai Mental Health Center. The digital therapy company said it is the first VR device of its kind for a specific phobia approved in the world.
Med-tech startups looking to enter the South Korean market might do so with the 2021 Global Inbound Membership Bridge to Korea, or B2K 2021 program, run by Shinhan Financial Group Co. Ltd.’s Shinhan Square Bridge Incheon. The organization fosters startups with business scale-up services, new market development, partnering and investment assistance. Six med-tech and digital health firms were selected in November 2021: Aevice Health Pte. Ltd., Fairphonic Pte. Ltd., NDR Medical Technology Pte. Ltd., Scanderm Pro LLC, Sqin and Vertliner Private Co.
Singular Health Group Ltd. entered a 50-50 joint venture in Macau that will explore the potential of Singular’s Scan to Surgery software for the East Asian market, which the company has long seen as a key opportunity for its 3D software and medical 3D printing ambitions.
New legislation providing a tax incentive for Australian medical innovations was introduced in Australia’s House of Representatives, and industry stakeholders are lauding the move. The measure, providing a special tax regime on income derived from patents, a “patent box,” will apply for income years beginning on or after July 1.
China’s NMPA has given 10 of Sihuan Pharmaceutical Holdings Group Ltd.’s skin repair products medical device registration certificates. The products are developed by its medical aesthetics platform, Beijing Meiyan Kongjian Biology Medicine Co. Ltd.
Saluda Medical Pty Ltd. raised $125 million in equity financing to commercialize and scale up its Evoke spinal cord simulation system for chronic pain and to advance its technology platform across an emerging portfolio of neuromodulation therapies.
Even as China sees strong and continuous growth in patent applications from its medical technology industry, regulators are imposing stricter regulations to curb what they see as "abnormal applications." China’s medical technology sector saw year-on-year growth of 28.7% in 2021 for valid invention patents, according to data from the China National Intellectual Property Administration.
Japan’s Ministry of Health, Labor and Welfare (MHLW) released a number of new guidelines and clarifications on medical device regulatory issues including cybersecurity, remanufactured single-use devices (SUDs) and the Medical Device Single Audit Program (MDSAP).
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