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BioWorld - Wednesday, April 8, 2026
Home » Topics » Asia-Pacific, Medical technology

Asia-Pacific, Medical technology
Asia-Pacific, Medical technology RSS Feed RSS

Two South Korean COVID-19 kits look overseas, seek FDA approval

March 24, 2020
By Gina Lee
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention. Two diagnostic kits made by domestic companies Seegene Inc.and Kogene Biotech Co. Ltd. are currently preparing to apply for U.S FDA approval.
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Australia and coronavirus

As Australia shuts its borders, the country looks within to manage COVID-19 pandemic

March 24, 2020
By Tamra Sami
PERTH, Australia – As Australia closes its borders to all non-citizens and non-residents, it looks within the country for solutions to manage the worsening COVID-19 pandemic.
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Antibody

Celltrion reaches milestone on COVID-19 super antibody

March 23, 2020
By Gina Lee
HONG KONG – Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally.
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Coronavirus test tubes

Atomo Diagnostics readies AU$30M IPO to ramp up manufacturing of COVID-19 rapid self-test

March 23, 2020
By Tamra Sami
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.
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Australian flag marking country on globe

TGA refines proposals to reclassify six groups of medical devices based on industry comments

March 18, 2020
By Tamra Sami
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).
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South Korean shield, coronavirus

South Korea approves first four COVID-19 test kits under urgent-use license

March 17, 2020
By Gina Lee
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.
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Map illustrating origin and spread of coronavirus

Undetected cases are major source of pandemic spread

March 16, 2020
By Anette Breindl
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.
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Australia map, flag

Australia unveils new regulatory framework for custom-made and 3D-printed devices

March 6, 2020
By Tamra Sami
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.
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3-5-Infervision-CT-COVID-19.png

China uses AI in medical imaging to speed up COVID-19 diagnosis

March 5, 2020
By Elise Mak
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.
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3-4-Biofourmis-Biovitals-Sentinel.png

Biofourmis’ AI remote monitoring platform deployed in Hong Kong COVID-19 program

March 4, 2020
By Meg Bryant
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.
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