PERTH, Australia – Australia’s TGA issued new guidance to help device manufacturers better understand new classifications for active medical devices, including software-based medical devices, and clinical decision support software.
A pan-cancer liquid biopsy solution that was developed by Twist Bioscience Corp. and Anchordx Medical Co. Ltd. has been launched globally. The companies will market the Twist Alliance Pan-Cancer Methylation Panel (Pan-Cancer Panel) jointly. The Pan-Cancer Panel is a solution for pan-cancer study including DNA methylation library preparation and targeted enrichment for next-generation sequencing (NGS).
Aum Biosciences Pte. Ltd., a company developing targeted cancer therapies, has closed a $27 million series A funding round. The Singapore-based company plans to use the proceeds to advance clinical development of its portfolio with immediate initiation of two phase II programs for MNK and tropomyosin receptor kinase inhibitors.
Chinese med-tech firms are still flocking to list on the Hong Kong Stock Exchange despite recent disappointing performances. One of these companies is Shanghai Microport Medbot (Group) Co. Ltd., which is looking to raise up to $1 billion in a Hong Kong initial public offering (IPO). Proceeds from the listing will be used for the R&D and commercialization of its core product Toumai Laparoscopic Surgical Robot.
PERTH, Australia – Molecular diagnostic company Speedx Pty Ltd. has invested in a Perth-based startup that makes the raw materials needed for polymerase chain reaction (PCR) COVID-19 tests. The two companies will work to develop a new at-home rapid PCR test to ensure Australia can become self-sufficient with producing PCR tests. A rapid PCR test that gives an accurate result in minutes could be used at home or work.
The COVID-19 pandemic has pushed India’s pharmaceutical and medical device industries towards the more widespread use of blockchain as part of a significant digital transformation effort underpinned by growing use of the Internet of Things (IoT), machine learning (ML) and the use of artificial intelligence (AI).
Through a series of notifications, India’s drug regulator has classified a new batch of medical devices as well as a range of software used in medical devices according to risk, taking another step to strengthen regulatory oversight and shore up the domestic med-tech sector.
Sumitomo Dainippon Pharma Co. Ltd., its U.S.-based subsidiary Sunovion Pharmaceuticals Inc. and Otsuka Pharmaceutical Co. Ltd. have inked a global collaboration agreement to jointly advance four new compounds for serious neuropsychiatric conditions. Sunovion granted Otsuka rights to collaboratively develop and commercialize the four compounds worldwide. In return, Sunovion will receive an up-front payment of $270 million and up to $620 million in development milestone payments for the agents, with the potential for more depending on additional indications. It could also receive sales milestones from Otsuka.
The COVID-19 pandemic has pushed India’s pharmaceutical and medical device industries towards the more widespread use of blockchain as part of a significant digital transformation effort underpinned by growing use of the Internet of Things (IoT), machine learning (ML) and the use of artificial intelligence (AI).
South Korea’s Cgbio Inc. has entered a partnership agreement with Singapore-based NDR Medical Technology Pte. Ltd. to introduce and test an automated needle targeting (ANT)-X system to assist surgeons during minimally invasive surgery. The system will combine artificial intelligence (AI) and medical image processing, based on core technology from NDR Medical.
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