PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking comments from industry on mandatory reporting of medical device averse events by health care facilities, and the agency also published comments on a consultation on patient information to be provided with devices. As part of the recent overhaul of Australia’s medical device regulations, the TGA released an action plan for medical devices in 2019 that explored whether it should be mandatory for health care facilities to report adverse events and safety problems with devices to the TGA.
PERTH, Australia – Investment in regenerative medicine in Australia in 2020 was AU$394.1 million (US295.8 million), accounting for nearly 23% of the overall capital invested in the Australian biotech sector, according to a new report published by Australia’s Regenerative Medicine Consortium.
PERTH, Australia – Singular Health Group Ltd. was awarded AU$50,000 (US$37,000) in funding from Australia’s Commonwealth Scientific and Industrial Research Organization’s (CSIRO) Kick-Start program to undertake a research project to develop artificial intelligence (AI)-based tools to automatically design patient-specific cranial implants. The AI will be integrated into Singular Health’s surgical planning software for editing before the cranial implants are 3D printed.
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.
PERTH, Australia – After meeting with the FDA, Medlab Clinical Ltd. is reformulating its cannabinoid pain product into a synthetic formulation because the agency indicated it was more likely to register a synthetic compared to a botanic.
PERTH, Australia – After meeting with the FDA, Medlab Clinical Ltd. is reformulating its cannabinoid pain product into a synthetic formulation because the agency indicated it was more likely to register a synthetic compared to a botanic.
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.
PERTH, Australia – Cynata Therapeutics Ltd. has regained rights to its Cymerus mesenchymal stem cell (MSC) product, CYP-001, for graft-vs.-host disease (GVHD) from former licensee Fujifilm Corp., with the two companies negotiating a new partnership under which Fujifilm will manufacture the product.
PERTH, Australia – Cynata Therapeutics Ltd. has regained rights to its Cymerus mesenchymal stem cell (MSC) product, CYP-001, for graft-vs.-host disease (GVHD) from former licensee Fujifilm Corp., with the two companies negotiating a new partnership under which Fujifilm will manufacture the product.
PERTH, Australia – As Australia prepares to reopen the country after strict lockdown measures, the TGA is making a new regulation to allow companies to supply their COVID-19 rapid antigen self-tests for home use beginning Nov. 1. “There’s light at the end of the tunnel for Australians on a number of fronts,” said Health Minister Greg Hunt in a Sept. 28 press conference.
