PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software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

PERTH, Australia – As of Feb. 12, Australia’s Department of Health confirmed 15 cases of novel coronavirus in Australia.

PERTH, Australia – Brisbane, Australia-based Field Orthopaedics was formed when a group of orthopedic surgeons were exasperated by ongoing shortcomings in surgical practice and decided to do something about it.

PERTH, Australia – As of Feb. 12, Australia’s Department of Health confirmed 15 cases of novel coronavirus in Australia (five in Queensland, four in New South Wales, four in Victoria and two in South Australia). Of the confirmed 15 cases, five people have recovered and the others are in stable condition.

PERTH, Australia – Mesoblast Ltd. has filed the final module of its rolling BLA submission for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, after it showed strong survival rates in children with acute steroid-refractory graft-vs.-host disease (aGVHD).

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking input from industry stakeholders on a proposal to increase its fees to cover projected deficits this year.

An international collaborative study led by geneticists at the Queensland Institute of Medical Research Berghofer Medical Research Institute (QIMR) in Brisbane, Australia, has used a multivariate approach to develop a polygenic risk score (PRS) for glaucoma.

An international collaborative study led by geneticists at the Queensland Institute of Medical Research Berghofer Medical Research Institute (QIMR) in Brisbane, Australia, has used a multivariate approach to develop a polygenic risk score (PRS) for glaucoma.