PERTH, Australia – After more than three years of consultations, Australia’s Therapeutic Goods Administration (TGA) finally has unveiled a new regulatory framework for custom-made and 3D-printed devices that aligns with international standards.

BEIJING – More and more companies and researchers in China are rolling out artificial intelligence (AI)-based systems that can process hundreds of computed tomography (CT) images in seconds to speed up diagnosis of COVID-19 and assist in its containment.

In an effort to gain new insights about the novel coronavirus sweeping the globe, Boston-based Biofourmis Inc. is leveraging its artificial intelligence (AI)-driven remote monitoring platform to monitor Hong Kong patients diagnosed or suspected of having COVID-19. The remote monitoring and disease surveillance program, which kicked off just a few days ago, is being administered by the University of Hong Kong and includes Biofourmis’ Hong Kong-based joint venture, Harmony Medical Inc.

HONG KONG – Japan cuts medical device prices every two years to manage increasing health care costs. This year, the biennial medical device price cut will take effect beginning on April 1, 2020.

PERTH, Australia – With the Brexit split now official, Australia’s Therapeutic Goods Administration (TGA) is trying to figure out the impact to its life sciences industry and the new trade relationships that will take effect after the transition period ends on Dec. 31, 2020.

Neurovasc Technologies Inc., of Laguna Hills, Calif., has entered a strategic partnership with the Wego Group that includes $34 million in funding to support the company’s product portfolio development and global clinical trial program. Specifically, the funding first will go toward studies of the company’s stent-retriever, designed to treat patients suffering an acute ischemic stroke, in markets such as Japan, the EU, U.S. and China.

LONDON – The COVID-19 epidemic has reached a “decisive point” as the number of new cases in the rest of the world exceeded the number of new cases in China, and seven countries reported infections for the first time.

LONDON – The COVID-19 outbreak appears to be sliding toward pandemic status, with the virus spreading to four more countries and confirmed cases and deaths mounting in infection hotspots in Italy, Iran and South Korea.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software as a medical device (SaMD).