PERTH, Australia – Australia’s Atomo Diagnostics Pty. Ltd. is preparing to raise AU$30 million (US$11.7 million) in an initial public offering on Australia’s Securities Exchange (ASX) that will enable it to ramp up manufacturing for rapid self-tests for COVID-19. The Sydney-based company is working with several multinational diagnostics companies to develop the new COVID-19 blood tests, which would be integrated with Atomo’s existing rapid test platform currently used for HIV screening.

PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Aug. 25, 2020, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).

Undetected cases were a major driver of the early spread of SARS-CoV-2 in Wuhan, China, despite being less infectious on a case-by-case basis, according to a modeling study published in the March 16, 2020, online issue of Science.

HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic kits to battle the pandemic in the country, which is home to one of the largest outbreaks in the world outside of China.

Undetected cases were a major driver of the early spread of SARS-CoV-2 in Wuhan, China, despite being less infectious on a case-by-case basis, according to a modeling study published in the March 16, 2020, online issue of Science.

HONG KONG - India has made amendments to the export policy of certain active pharmaceutical ingredients (APIs) and the formulations based on some specific APIs.

HONG KONG – Cadila Healthcare Ltd. (Zydus Cadila) has won approval for its saroglitazar to be used as the treatment of non-cirrhotic nonalcoholic steatohepatitis (NASH) in India. The green light from the Drug Controller General of India (DCGI) makes saroglitazar the first drug in the world approved for this indication.

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.